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Item 1A. Risk Factors

2023-12-15 compared with 2022-12-22 · 1293 added, 1206 removed, 400 unchanged (86% of the section changed)

Summary of Risk Factors

The risk factors summarized

and detailed below could materially harm our business, operating results and financial condition, impair our future prospects and cause

the price of our common stock to decline.

These are not all of the risks we face and other factors not presently known to us or that we

currently believe are immaterial may also affect our business if they occur.

Material risks that may affect our business, operating results

and financial condition include, but are not necessarily limited to, those relating to:

● we have incurred significant operating losses since inception and cannot assure you that we will ever

achieve or sustain profitability;

● our ability to continue our operations requires that we raise additional capital and our operations could

be curtailed if we are unable to obtain the additional funding as or when needed;

● the COVID-19 pandemic has adversely impacted and will likely continue to adversely impact our business,

including through component shortages, including of our primary component, polyimide film, due to supply chain shortages attributed to

COVID related issues, supply chain disruptions, including related to staffing availability, and delays in product availability and delivery,

impacts on pre-clinical and clinical trials and regulatory clearances/approvals;

● we will need to raise substantial additional funds in the future, and these funds may not be available

on acceptable terms or at all.

A failure to obtain this necessary capital when needed could force us to delay, limit, scale back or cease

some or all operations;

● medical device development involves a lengthy and expensive process, with an uncertain outcome.

incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization

of any product;

● changes in the configuration of our cortical strip, grid electrode and depth electrode technology under

development may result in additional costs or delay;

● if we are unable to successfully develop, receive regulatory clearance/approval for and commercialize

our technology and other products under development, or if we experience significant delays in doing so, our business will be harmed;

● failure to secure or retain coverage or adequate reimbursement for our cortical strip, grid electrode

and depth electrode technology or future versions thereof, including the implantation procedures, by third-party payors could adversely

affect our business, financial condition and operating results;

● if our competitors are better able to develop and market products for the diagnosis and treatment of epilepsy,

Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders

that are safer, more effective, less costly, easier to use or otherwise more attractive than our cortical strip, grid electrode and depth

electrode technology, our business will be adversely impacted;

● the size and future growth in the market for our cortical strip, grid electrode and depth electrode technology

under development has not been established with precision and may be smaller than we estimate, possibly materially;

NeuroOne Medical Technologies Corporation

● we depend on intellectual property licensed from WARF for our technology under development, and the termination

of this license would harm our business;

● we depend on our partnership with Mayo to license certain know how for the development and commercialization

of our technology.

Termination of this partnership would harm our business, and even if this partnership continues, it may not be successful;

● even if we have our cortical strip, grid electrode and depth electrode technology approved for commercial

sale, if we are unable to expand our sales and marketing infrastructure, we may not be successful in commercializing our cortical strip,

grid electrode and depth electrode technology in the United States;

● we contract with third parties for the manufacture of our cortical strip, grid electrode and depth electrode

technology under development and expect to continue to do so for clinical trials and commercialization.

Risks associated with the manufacturing

of our products could reduce our gross margins and negatively affect our operating results;

● if we or our third-party suppliers or manufacturers fail to comply with the FDA’s good manufacturing

practice regulations, this could impair our ability to market our products in a cost-effective and timely manner;

● potential complications from our cortical strip, grid electrode and depth electrode technology that are

currently unknown may come to light;

● if there are significant disruptions in our information technology systems, our business, financial condition

and operating results could be adversely affected;

● we have entered into, and may enter into collaborations, in-licensing arrangements, joint ventures, strategic

alliances or partnerships with third-parties that may not result in the development of commercially viable products or the generation

of significant future revenues;

● our future success depends on our ability to retain key executives and to attract, retain and motivate

qualified personnel;

● our ability to protect our intellectual property and proprietary technology is uncertain;

● we may be subject to damages resulting from claims that we, or our employees, have wrongfully used or

disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors;

● our products and operations are subject to extensive governmental regulation, and failure to comply with

applicable requirements could cause our business to suffer;

● the price of our Common Stock might fluctuate significantly, and you could lose all or part of your investment;

● we intend to issue more shares to raise capital, which will result in substantial dilution.

NeuroOne Medical Technologies Corporation

Risks Related to Our Business

We have incurred significant operating

losses since inception and cannot assure you that we will ever achieve or sustain profitability.

We have incurred losses since inception, and as

of September 30, 2022, we had an accumulated deficit of $ 50.8 million primarily as a result

of Risk Factors

risk factors summarized and detailed below could materially harm our business, operating results and financial condition, impair our

future prospects and cause the price of our common stock to decline.

These are not all of the risks we face and other factors not presently

known to us or that we currently believe are immaterial may also affect our business if they occur.

Material risks that may affect our

business, operating results and financial condition include, but are not necessarily limited to, those relating to:

have incurred significant operating losses since inception and cannot assure you that we will ever achieve or sustain profitability;

ability to continue our operations requires that we raise additional capital and our operations could be curtailed if we are unable to

obtain the additional funding as or when needed;

will need to raise substantial additional funds in the future, and these funds may not be available on acceptable terms or at all.

failure to obtain this necessary capital when needed could force us to delay, limit, scale back or cease some or all operations;

device development involves a lengthy and expensive process, with an uncertain outcome.

We may incur additional costs or experience delays

in completing, or ultimately be unable to complete, the development and commercialization of any product;

in the configuration of our cortical strip, grid electrode and depth electrode technology under development may result in additional

costs or delay;

we are unable to successfully develop, receive regulatory clearance/approval for and commercialize our technology and other products

under development, or if we experience significant delays in doing so, our business will be harmed;

to secure or retain coverage or adequate reimbursement for our cortical strip, grid electrode and depth electrode technology or future

versions thereof, including the implantation procedures, by third-party payors could adversely affect our business, financial condition

and operating results;

Medical Technologies Corporation

our competitors are better able to develop and market products for the diagnosis and treatment of epilepsy, Parkinson’s disease,

dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that are safer, more

effective, less costly, easier to use or otherwise more attractive than our cortical strip, grid electrode and depth electrode technology,

our business will be adversely impacted;

size and future growth in the market for our cortical strip, grid electrode and depth electrode technology under development has not

been established with precision and may be smaller than we estimate, possibly materially;

depend on intellectual property licensed from WARF for our technology under development, and the termination of this license would harm

our business;

depend on our partnership with Mayo to license certain know how for the development and commercialization of our technology.

of this partnership would harm our business, and even if this partnership continues, it may not be successful;

if we have our cortical strip, grid electrode and depth electrode technology approved for commercial sale, if we are unable to expand

our sales and marketing infrastructure, we may not be successful in commercializing our cortical strip, grid electrode and depth electrode

technology in the United States;

contract with third parties for the manufacture of our cortical strip, grid electrode and depth electrode technology under development

and expect to continue to do so for clinical trials and commercialization.

Risks associated with the manufacturing of our products could

reduce our gross margins and negatively affect our operating results;

we or our third-party suppliers or manufacturers fail to comply with the FDA’s good manufacturing practice regulations, this could

impair our ability to market our products in a cost-effective and timely manner;

complications from our cortical strip, grid electrode and depth electrode technology that are currently unknown may come to light;

there are significant disruptions in our information technology systems, our business, financial condition and operating results could

be adversely affected;

have entered into, and may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships

with third-parties that may not result in the development of commercially viable products or the generation of significant future revenues;

future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel;

have been the victim of a cyber-related crime and our controls may not be successful in avoiding further cyber-related crimes in the

ability to protect our intellectual property and proprietary technology is uncertain;

may be subject to damages resulting from claims that we, or our employees, have wrongfully used or disclosed alleged trade secrets of

our competitors or are in breach of non-competition or non-solicitation agreements with our competitors;

products and operations are subject to extensive governmental regulation, and failure to comply with applicable requirements could cause

our business to suffer;

price of our Common Stock might fluctuate significantly, and you could lose all or part of your investment;

intend to issue more shares to raise capital, which will result in substantial dilution.

Medical Technologies Corporation

Related to Our Business

have incurred significant operating losses since inception and cannot assure you that we will ever achieve or sustain profitability.

have incurred losses since inception, and as of September 30, 2023, we had an accumulated deficit of $62.7 million primarily as a result

of expenses incurred in connection with our operations and from our research and development programs.

3 unchanged sentences

There was also substantial doubt about the Company’s ability to continue

as a going concern as of and for the year ended September 30, 2021 To date, we have financed our operations primarily through debt and

as a going concern as of and for the year ended September 30, 2022.

To date, we have financed our operations primarily through debt and

equity financings, and our primary activities have been limited to, and our limited resources have been dedicated to, performing business

1 unchanged sentence

property and conducting development activities.

To implement our business strategy we need to,

among other things, develop an all-in-one diagnostic and therapeutic solution, successfully complete the necessary testing and clinical

trials required for regulatory approval of our technology for ablation and stimulation therapies, gain approval for other brain or motor

related disorders such as Parkinson’s with the therapeutic technologies developed for epilepsy, convince physicians and patients

that our technology, if approved, represents an improvement over existing diagnostic or treatment options, hire direct experienced sales

representatives to market our technology, and engage in beneficial partnerships that can leverage our core technology.

We have never been

profitable and do not expect to be profitable in the foreseeable future.

We expect our expenses to increase significantly as we pursue

our objectives.

The extent of our future operating losses and the timing of profitability are highly uncertain, and we expect to continue

incurring significant expenses and operating losses over the next several years.

Our prior losses have had, and will continue to have,

an adverse effect on our stockholders’ equity and working capital.

Any additional operating losses may have an adverse effect on

our stockholders’ equity, and we cannot assure you that we will ever be able to achieve profitability.

Even if we achieve profitability,

we may not be able to sustain or increase profitability on a quarterly or annual basis.

Our failure to become and remain profitable would

depress the value of our Company and could impair our ability to raise capital, expand our business, maintain our development efforts,

obtain regulatory approvals or continue our operations.

We have a limited operating history,

making it difficult for you to evaluate our business and your investment.

We are an early-stage medical technology company

developing comprehensive neuromodulation cEEG and sEEG monitoring, ablation, and brain stimulation solutions to diagnose and treat patients

with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological

Our operations are subject to all of the risks inherent in the establishment of a new business enterprise, including but not

limited to the absence of an operating history, lack of fully-developed or commercialized products, insufficient capital, expected substantial

and continual losses for the foreseeable future, limited experience in dealing with regulatory issues, lack of manufacturing and marketing

experience, need to rely on third parties for the development and commercialization of our proposed products, a competitive environment

characterized by well-established and well-capitalized competitors and reliance on key personnel.

From our inception through September 30, 2022,

we have generated limited revenue from the commercial sales of our products.

Because we have generated very limited revenues from commercialization,

our operations to date have been principally financed through public and private offerings of our Common Stock and convertible debt and

exercises of options and warrants.

Investors are subject to all the risks incident

to the creation and development of a new business and each investor should be prepared to withstand a complete loss of his, her or its

Furthermore, the accompanying financial statements have been prepared assuming that we will continue as a going concern.

the factors included above raise substantial doubt about our ability to continue as a going concern.

Our financial statements do not include

any adjustments that might result from the outcome of this uncertainty.

NeuroOne Medical Technologies Corporation

Our Company has limited experience in medical

device development and may not be able to successfully develop any device or therapy.

Our ability to become profitable depends primarily

our ability to further develop our cortical strip, grid electrode and depth electrode technology, our successful completion of all

necessary pre-clinical testing and clinical trials on such technology, our ability to obtain clearance or approval for such technology

and successfully commercialize such technology, our ongoing research and development efforts, the timing and cost of clinical trials,

our ability to identify personnel with the necessary skill sets or enter into favorable alliances with third-parties who can provide substantial

capabilities in clinical development, regulatory affairs, sales, marketing and distribution and our ability to obtain and maintain necessary

intellectual property rights to such technology.

Our limited experience in medical device development may make it more difficult for us

to complete these tasks.

Even if we successfully develop and market such

technology, we may not generate sufficient or sustainable revenue to achieve or sustain profitability, which could cause us to cease operations

and cause you to lose all of your investment.

Our ability to continue our operations

requires that we raise additional capital and our operations could be curtailed if we are unable to obtain the additional funding as or

Our independent registered public accounting

firm included an explanatory paragraph in the report on our financial statements as of and for the years ended September 30, 2022

and 2021, respectively, noting the existence of substantial doubt about our ability to continue as a going concern.

At September 30,

2022, we had cash, cash equivalents and short-term investments in the aggregate of approximately $11.1 million.

Our existing cash,

cash equivalents and short-term investments will not be sufficient to fund our operating expenses.

implement our business strategy we need to, among other things, develop an all-in-one diagnostic and therapeutic solution, successfully

complete the necessary testing and clinical trials required for regulatory approval of our technology for ablation and stimulation therapies,

gain approval for other brain or motor related disorders such as Parkinson’s with the therapeutic technologies developed for epilepsy,

convince physicians and patients that our technology, if approved, represents an improvement over existing diagnostic or treatment options,

hire direct experienced sales representatives to market our technology, and engage in beneficial partnerships that can leverage our core

We have never been profitable and do not expect to be profitable in the foreseeable future.

We expect our expenses to increase

significantly as we pursue our objectives.

The extent of our future operating losses and the timing of profitability are highly uncertain,

and we expect to continue incurring significant expenses and operating losses over the next several years.

Our prior losses have had,

and will continue to have, an adverse effect on our stockholders’ equity and working capital.

Any additional operating losses may

have an adverse effect on our stockholders’ equity, and we cannot assure you that we will ever be able to achieve profitability.

Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.

to become and remain profitable would depress the value of our Company and could impair our ability to raise capital, expand our business,

maintain our development efforts, obtain regulatory approvals or continue our operations.

have a limited operating history, making it difficult for you to evaluate our business and your investment.

are an early-stage medical technology company developing comprehensive neuromodulation cEEG and sEEG monitoring, ablation, and brain

stimulation solutions to diagnose and treat patients with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain

due to failed back surgeries and other related neurological disorders.

Our operations are subject to all of the risks inherent in the

establishment of a new business enterprise, including but not limited to the absence of an operating history, lack of fully-developed

or commercialized products, insufficient capital, expected substantial and continual losses for the foreseeable future, limited experience

in dealing with regulatory issues, lack of manufacturing and marketing experience, need to rely on third parties for the development

and commercialization of our proposed products, a competitive environment characterized by well-established and well-capitalized competitors

and reliance on key personnel.

our inception through September 30, 2023, we have generated limited revenue from the commercial sales of our products.

Because we have

generated very limited revenues from commercialization, our operations to date have been principally financed through public and private

offerings of our Common Stock and convertible debt and exercises of options and warrants.

are subject to all the risks incident to the creation and development of a new business and each investor should be prepared to withstand

a complete loss of his, her or its investment.

Furthermore, the accompanying financial statements have been prepared assuming that we

will continue as a going concern.

However, the factors included above raise substantial doubt about our ability to continue as a going

Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Medical Technologies Corporation

Company has limited experience in medical device development and may not be able to successfully develop any device or therapy.

to become profitable depends primarily on:

our ability to further develop our cortical strip, grid electrode and depth electrode technology,

our successful completion of all necessary pre-clinical testing and clinical trials on such technology, our ability to obtain clearance

or approval for such technology and successfully commercialize such technology, our ongoing research and development efforts, the timing

and cost of clinical trials, our ability to identify personnel with the necessary skill sets or enter into favorable alliances with third-parties

who can provide substantial capabilities in clinical development, regulatory affairs, sales, marketing and distribution and our ability

to obtain and maintain necessary intellectual property rights to such technology.

Our limited experience in medical device development

may make it more difficult for us to complete these tasks.

if we successfully develop and market such technology, we may not generate sufficient or sustainable revenue to achieve or sustain profitability,

which could cause us to cease operations and cause you to lose all of your investment.

ability to continue our operations requires that we raise additional capital and our operations could be curtailed if we are unable to

obtain the additional funding as or when needed.

independent registered public accounting firm included an explanatory paragraph in the report on our financial statements as of and for

the years ended September 30, 2023 and 2022, respectively, noting the existence of substantial doubt about our ability to continue as

a going concern.

At September 30, 2023, we had cash and cash equivalents in the aggregate of approximately $5.3 million.

cash, cash equivalents and short-term investments will not be sufficient to fund our operating expenses.

To continue to fund operations,

we will need to secure additional funding.

We may obtain additional financing in the future through the issuance of our Common

Stock, through other equity or debt financings or through collaborations or partnerships with other companies.

We may not be able to

raise additional capital on terms acceptable to us, or at all.

The COVID-19 pandemic has adversely

impacted, and may continue to impact, our business.

Since the beginning of the COVID-19 pandemic,

governments, public institutions, and other organizations have taken and are continuing to take certain preventative or protective measures

to combat the transmission of the virus, including implementation of travel restrictions or bans, vaccination mandates, closures of non-essential

businesses, limitations of public gatherings, other social distancing and shelter-in-place measures, and delays or cancellations of elective

The Company, our employees, contractors, suppliers, and other partners may be prevented from conducting business activities

for an indefinite period of time due to shutdowns or other regulatory requirements that may be requested or mandated by state and federal

governmental authorities.

NeuroOne Medical Technologies Corporation

We have experienced, and will likely continue

to experience, disruptions that could negatively or severely impact our business and planned clinical trials, including:

● delays or difficulties in conducting pre-clinical and clinical trials;

● interruption in global manufacturing and shipping, including testing equipment and personal protective

equipment used at our facilities;

● material shortages for manufacturing, including those the Company is currently experiencing related to

its primary component, polyimide film, due to supply chain shortages attributed to COVID related issues;

● delays in timelines for product availability and delivery from vendors, including related to staffing

shortages, both generally and due to employee illness, and due to increases in demand from other larger or more longstanding customers

of our suppliers placing large orders due to concerns with supply chain disruption and the impact of COVID-19;

● changes in local regulations as part of a response to the COVID-19 pandemic, which may require us to change

the way in which clinical trials are conducted and may result in unexpected costs;

● delay in the timing of interactions with the FDA due to absenteeism by federal employees or by the diversion

of their efforts and attention to approval of other therapeutics or other activities related to COVID-19.

In addition, COVID-19 could disrupt our operations

due to absenteeism by infected or ill members of management or other employees, or absenteeism by members of management and other employees

who elect not to come to work due to the illness affecting others in our office or laboratory facilities, or due to quarantines.

illness could also impact members of our Board and its ability to hold meetings.

As the COVID-19 pandemic continues to adversely

affect our operating and financial results, it may also have the effect of heightening many of the other risks described in the risk factors

in this Report.

Further, the COVID-19 pandemic may also affect our operating and financial results in a manner that is not presently known

to us or that we currently do not expect to present significant risks to our operations or financial results, particularly if the COVID-19

pandemic and its associated impacts reoccur in successive waves in the coming months.

NeuroOne Medical Technologies Corporation

We will need to raise substantial

additional funds in the future, and these funds may not be available on acceptable terms or at all.

A failure to obtain this necessary

capital when needed could force us to delay, limit, scale back or cease some or all operations.

The continued growth of our business, including

the development, regulatory approval and commercialization of our cortical strip, grid electrode and depth electrode technology, will

significantly increase our expenses going forward.

As a result, we will be required to seek substantial additional funds in the future.

We may obtain additional financing in the future through the issuance of our Common Stock,

through other equity or debt financings or through collaborations or partnerships with other companies.

We may not be able to raise additional

capital on terms acceptable to us, or at all.

global economic conditions could have a negative effect on our business, results of operations and financial condition and liquidity.

general slowdown in the global economy, including a recession, or in a particular region or industry, an increase in trade tensions with

trading partners, inflation or a tightening of the credit markets could negatively impact our business, financial condition and

Adverse global economic conditions have from time to time caused or exacerbated significant slowdowns in the industries and

markets in which we operate, which have adversely affected our business and results of operations.

Macroeconomic weakness and uncertainty

also make it more difficult for us to accurately forecast revenue, gross margin and expenses, and may make it more difficult to raise

or refinance debt.

economic and social instability could adversely affect our revenue, financial condition, or results of operations.

worldwide economic conditions remain uncertain, particularly due to the effects of the conflict between Russia and Ukraine and potentially

between Israel and Hamas, disruptions in the banking system and financial markets, lingering COVID-19 pandemic, increased inflation and

rising interest rates.

The general economic and capital market conditions, both in the U.S.

and worldwide, have been volatile in the

past and at times have adversely affected the Company’s access to capital and increased the cost of capital.

The capital and credit

markets may not be available to support future capital raising activity on favorable terms.

If economic conditions decline, the Company’s

future cost of equity or debt capital and access to the capital markets could be adversely affected.

Our vendors and development partners

may experience financial difficulties or be unable to borrow money to fund their operations, which may adversely impact their ability

to purchase our products or to pay for our products on a timely basis, if at all.

In addition, adverse economic conditions, such as recent

supply chain disruptions and labor shortages and persistent inflation, have affected, and may continue to adversely affect our suppliers’

ability to provide our manufacturers with materials and components, which may negatively impact our business.

These economic conditions

make it more difficult for us to accurately forecast and plan our future business activities.

Medical Technologies Corporation

will need to raise substantial additional funds in the future, and these funds may not be available on acceptable terms or at all.

failure to obtain this necessary capital when needed could force us to delay, limit, scale back or cease some or all operations.

continued growth of our business, including the development, regulatory approval and commercialization of our cortical strip, grid electrode

and depth electrode technology, will significantly increase our expenses going forward.

As a result, we will be required to seek substantial

additional funds in the future.

Our future capital requirements will depend on many factors, including:

● the cost of further developing our cortical strip, grid electrode and depth electrode technology;

● obtaining and maintaining regulatory clearance or approval for our cortical strip, grid electrode and

cost of further developing our cortical strip, grid electrode and depth electrode technology;

and maintaining regulatory clearance or approval for our cortical strip, grid electrode and

depth electrode technology;

● the costs associated with commercializing our cortical strip, grid electrode and depth electrode technology;

● any change in our development priorities;

● the revenue generated by sales of our cortical strip, grid electrode and depth electrode technology;

● the costs associated with expanding our sales and marketing infrastructure for commercialization of our

cortical strip grid electrode and depth electrode technology;

● any change in our plans regarding the manner in which we choose to commercialize any approved product

in the United States;

● the cost of ongoing compliance with regulatory requirements;

● expenses we incur in connection with potential litigation or governmental investigations;

● expenses and costs we incur in connection with changes in the economy and regulatory process in connection

with the COVID-19 pandemic;

● the costs to develop additional intellectual property;

● anticipated or unanticipated capital expenditures;

● unanticipated general and administrative expenses.

As a result of these and other factors, we do

not know whether and the extent to which we may be required to raise additional capital.

We may in the future seek additional capital

from public or private offerings of our capital stock, borrowings under credit lines or other sources.

We may not be able to raise additional capital

on terms acceptable to us, or at all.

Any failure to raise additional capital could compromise our ability to execute on our business

plan, and we may be forced to liquidate our assets.

In such a scenario, the values we receive for our assets in liquidation or dissolution

could be significantly lower than the values reflected in our financial statements.

If we issue additional equity or debt securities

to raise additional funds, our existing stockholders may experience dilution, and the new equity or debt securities may have rights, preferences

and privileges senior to those of our existing stockholders.

In addition, if we raise additional funds through collaborations, licensing,

joint ventures, strategic alliances, partnership arrangements or other similar arrangements, it may be necessary to relinquish valuable

rights to our potential future products or proprietary technologies or grant licenses on terms that are not favorable to us.

NeuroOne Medical Technologies Corporation

Changes in the configuration of our

cortical strip, grid electrode and depth electrode technology under development may result in additional costs or delay.

As products are developed through pre-clinical

testing and clinical trials towards approval and commercialization, it is common that various aspects of the development program, such

as manufacturing methods and configuration, are altered along the way in an effort to optimize processes and results.

Any changes we make

carry the risk that they will not achieve the intended objectives.

Any of these changes could cause our products to perform differently

and affect the results of planned clinical trials or other future clinical trials conducted with the altered device.

Such changes may

also require additional testing, regulatory notification or regulatory approval.

This could delay completion of pre-clinical testing or

clinical trials, increase costs, delay approval of our future products and jeopardize our ability to commence sales and generate revenue.

We have two products, our cortical

strip and grid electrodes and our sEEG electrode technology, which have each received 510(k) clearance from the FDA.

If we are unable

to successfully develop, and receive regulatory clearance/approval for our other products under development, or if we experience significant

delays in doing so, our business will be harmed.

Two of our products have received 510(k) clearance

costs associated with commercializing our cortical strip, grid electrode and depth electrode

change in our development priorities;

revenue generated by sales of our cortical strip, grid electrode and depth electrode technology;

costs associated with expanding our sales and marketing infrastructure for commercialization

of our cortical strip grid electrode and depth electrode technology;

change in our plans regarding the manner in which we choose to commercialize any approved

product in the United States;

cost of ongoing compliance with regulatory requirements;

we incur in connection with potential litigation or governmental investigations;

and costs we incur in connection with changes in the economy and regulatory process;

costs to develop additional intellectual property;

● anticipated

or unanticipated capital expenditures;

● unanticipated

general and administrative expenses.

a result of these and other factors, we do not know whether and the extent to which we may be required to raise additional capital.

may in the future seek additional capital from public or private offerings of our capital stock, borrowings under credit lines or other

may not be able to raise additional capital on terms acceptable to us, or at all.

Any failure to raise additional capital could compromise

our ability to execute on our business plan, and we may be forced to liquidate our assets.

In such a scenario, the values we receive

for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements.

we issue additional equity or debt securities to raise additional funds, our existing stockholders may experience dilution, and the new

equity or debt securities may have rights, preferences and privileges senior to those of our existing stockholders.

In addition, if we

raise additional funds through collaborations, licensing, joint ventures, strategic alliances, partnership arrangements or other similar

arrangements, it may be necessary to relinquish valuable rights to our potential future products or proprietary technologies or grant

licenses on terms that are not favorable to us.

Medical Technologies Corporation

in the configuration of our cortical strip, grid electrode and depth electrode technology under development may result in additional

costs or delay.

products are developed through pre-clinical testing and clinical trials towards approval and commercialization, it is common that various

aspects of the development program, such as manufacturing methods and configuration, are altered along the way in an effort to optimize

processes and results.

Any changes we make carry the risk that they will not achieve the intended objectives.

Any of these changes could

cause our products to perform differently and affect the results of planned clinical trials or other future clinical trials conducted

with the altered device.

Such changes may also require additional testing, regulatory notification or regulatory approval.

delay completion of pre-clinical testing or clinical trials, increase costs, delay approval of our future products and jeopardize our

ability to commence sales and generate revenue.

have two products, our cortical strip and grid electrodes and our sEEG electrode technology, which have each received 510(k) clearance

from the FDA.

Our Evo cortical electrode technology has received 510(k) clearance from the FDA for recording, monitoring, and stimulating

brain tissue on the surface of the brain for less than 30 days, and our Evo sEEG electrode technology has received 510(k) clearance from

the FDA for use (less than 30 days) with recording, monitoring, and stimulation equipment for recording, monitoring, and stimulation of

electrical signals at the subsurface level of the brain.

None of our other products have received clearance or approval for commercial

Our ability to generate revenue from our developed products, if any, will depend heavily on their successful development and regulatory

Before obtaining marketing clearance or approval

from regulatory authorities for the sale of our cortical strip, grid electrode and depth electrode technology under development in the

United States for certain indications, we must complete all pre-clinical testing, clinical trials and other regulatory requirements necessitated

by the FDA and demonstrate the performance and safety of our technology.

Clinical testing is expensive, difficult to design and implement,

can take many years to complete and is inherently uncertain as to outcome.

A failure of one or more clinical trials can occur at any stage

Further, the outcomes of completed clinical trials may not be predictive of the success of later clinical trials, and interim

results of a clinical trial do not necessarily predict final results.

Clinical data is often susceptible to varying interpretations and

analyses, and many companies that have believed their products performed satisfactorily in clinical trials have nonetheless failed to

obtain marketing clearance or approval.

We have limited resources to complete the expensive process of medical device development, pre-clinical

testing and clinical trials, putting us at a disadvantage, particularly compared to some of our larger and established competitors, and

we may not have sufficient resources to commercialize our products under development in a timely fashion, if ever.

We may experience numerous unforeseen events during

or as a result of clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our products,

● regulators may not authorize us or our investigators to commence a clinical trial or conduct a clinical

If we are unable to successfully develop, and receive regulatory clearance/approval for our other products under development,

or if we experience significant delays in doing so, our business will be harmed.

of our products have received 510(k) clearance from the FDA.

Our Evo cortical electrode technology has received 510(k) clearance from

the FDA for recording, monitoring, and stimulating brain tissue on the surface of the brain for less than 30 days, and our Evo sEEG electrode

technology has received 510(k) clearance from the FDA for use (less than 30 days) with recording, monitoring, and stimulation equipment

for recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

Our OneRF ablation system has

received 510(k) clearance from the FDA for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

None of our other products have received clearance or approval for commercial sale.

Our ability to generate revenue from our developed

products, if any, will depend heavily on their successful development and regulatory approval.

obtaining marketing clearance or approval from regulatory authorities for the sale of our cortical strip, grid electrode and depth electrode

technology under development in the United States for certain indications, we must complete all pre-clinical testing, clinical trials

and other regulatory requirements necessitated by the FDA and demonstrate the performance and safety of our technology.

Clinical testing

is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome.

of one or more clinical trials can occur at any stage of testing.

Further, the outcomes of completed clinical trials may not be predictive

of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results.

Clinical data

is often susceptible to varying interpretations and analyses, and many companies that have believed their products performed satisfactorily

in clinical trials have nonetheless failed to obtain marketing clearance or approval.

We have limited resources to complete the expensive

process of medical device development, pre-clinical testing and clinical trials, putting us at a disadvantage, particularly compared

to some of our larger and established competitors, and we may not have sufficient resources to commercialize our products under development

in a timely fashion, if ever.

may experience numerous unforeseen events during or as a result of clinical trials that could delay or prevent our ability to receive

marketing approval or commercialize our products, including:

may not authorize us or our investigators to commence a clinical trial or conduct a clinical

trial at a prospective trial site;

● the failure to successfully complete pre-clinical testing requirements required by the FDA;

● we may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts

with third parties or clinical trial protocols with prospective trial sites, the terms of which can be subject to extensive negotiation

and may vary significantly among different trial sites;

NeuroOne Medical Technologies Corporation

● clinical trials of our cortical strip, grid electrode and depth electrode technology may produce negative

or inconclusive results, including failure to demonstrate statistical significance, and we may decide, or regulators may require us, to

conduct additional clinical trials or abandon our development programs;

● the number of people with brain related disorders required for clinical trials may be larger than we anticipate,

enrollment in these clinical trials may be slower than we anticipate or people may drop out of these clinical trials or fail to return

for post-treatment follow-up at a higher rate than we anticipate;

● our products may have unanticipated adverse events, undesirable side effects or other unexpected characteristics,

causing us or our investigators, regulators or institutional review boards to suspend or terminate the trials;

● our third-party contractors conducting the clinical trials may fail to comply with regulatory requirements

or meet their contractual obligations to us in a timely manner, or at all;

● regulators may require that we or our investigators suspend or terminate clinical development for various

reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health

● the cost of clinical trials of our products may be greater than we anticipate;

● the supply or quality of our products or other materials necessary to conduct clinical trials of our products

may be insufficient or inadequate;

● the COVID-19 pandemic may cause delays and disruptions in the supply chain, clinical trials, clinical

development, and regulatory approval process;

● delays from our suppliers and manufacturers could impact clinical trial completion and impact revenue.

If we are required to conduct additional clinical

trials or other testing of our cortical strip, grid electrode and depth electrode technology under development beyond those that we contemplate,

if we are unable to successfully complete clinical trials, if the results of these trials or tests are not favorable or if there are safety

concerns, we may:

● not obtain marketing approval at all;

● be delayed in obtaining marketing approval for our cortical strip, grid electrode and depth electrode

technology under development in a jurisdiction;

● be subject to additional post-marketing testing requirements;

● have our cortical strip, grid electrode and depth electrode technology removed from the market after obtaining

marketing approval.

Our development costs will also increase if we

experience delays in testing or marketing approvals, including, but not limited to, the COVID-19 pandemic.

We do not know whether any

of our clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all.

Significant clinical

trial delays also could allow our competitors to bring innovative products to market before we do and impair our ability to successfully

commercialize our products.

NeuroOne Medical Technologies Corporation

Even if we obtain regulatory clearance

and/or approval for all of our products, we will remain subject to extensive regulatory scrutiny and compliance obligations.

Both before and after a product is commercially

released, we will have ongoing responsibilities under FDA regulations.

We will also be subject to periodic inspections by the FDA and

comparable foreign authorities to determine compliance with regulatory requirements, such as the Quality System Regulation, or QSR, of

the FDA, medical device reporting regulations and regulations regarding notification, corrections, and recalls.

These inspections can

result in observations or reports, warning letters or other similar notices or forms of enforcement action.

If the FDA concludes that

we are not in compliance with applicable laws or regulations, or that any of our products are ineffective or pose an unreasonable health

risk, it could ban these products, suspend or cancel our marketing authorizations, impose “stop-sale” and “stop-import”

orders, detain or seize adulterated or misbranded products, order a recall, repair, replacement, correction or refund of such products,

or require us to notify health providers and others that the products present unreasonable risks of substantial harm to the public health.

Discovery of previously unknown problems with our product’s design or manufacture may result in restrictions on use, restrictions

placed on us or our suppliers, or withdrawal of an existing regulatory clearance.

The FDA may also impose operating restrictions, enjoin

and restrain certain violations of applicable law pertaining to medical devices, assess civil or criminal penalties against our officers,

employees or us, or recommend criminal prosecution of our Company.

Adverse regulatory action may restrict us from effectively marketing

and selling our products.

In addition, negative publicity and product liability claims resulting from any adverse regulatory action could

have a material adverse effect on our business, financial condition, and operating results.

In addition, even though we have obtained FDA

clearance to market two of our products, and even if we obtain the proper regulatory approval or clearance to market any additional products

under development, the FDA has the power to require us to conduct post-market surveillance studies, which are designed to identify adverse

events, device malfunctions or complaints from patients implanted with the device during a specified period after the commencement of

commercial use in the U.S.

The FDA may also require us to conduct post-approval studies to further monitor the safety and/or effectiveness

of our products.

Failure to conduct required surveillance or studies in a timely manner could result in the revocation of the approved

PMA product that is subject to such a requirement and could also result in the recall or withdrawal of the product, which would prevent

us from generating sales from that product in the United States.

We may not be successful in commercializing

our cortical strip, grid electrode and depth electrode.

We anticipate that we will derive nearly all of

revenue from the sales of our cortical strip, grid electrode and depth electrode technology or future versions thereof.

Moreover, we expect the revenue opportunity for

additional uses of our technology to be greater than the technology and uses that have currently been cleared by the FDA, and so we believe

our ability to generate significant revenue in the future will be dependent upon the receipt of additional FDA clearances.

Our revenue will be dependent, in part, upon the

size of the markets in which we gain regulatory approval, the accepted price for the product, the ability to obtain coverage and reimbursement,

and whether we own the commercial rights for that territory.

If the number of people we target is not as significant as we estimate or

the treatment population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue

from sales of such products, even if approved.

The success of any products that we develop will

depend on several factors, including:

● receipt of timely commercialization approvals from applicable regulatory authorities;

● our ability to procure and maintain suppliers and manufacturers of the components of our current cortical

strip, grid electrode and depth electrode technology and future versions;

NeuroOne Medical Technologies Corporation

● launching commercial sales of our cortical strip, grid electrode and depth electrode technology, if approved

for marketing;

● market acceptance of our cortical strip, grid electrode and depth electrode technology, if approved, by

people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related

neurological disorders, the medical community and third-party payors;

● our success in educating healthcare providers and people with epilepsy, Parkinson’s disease, dystonia,

essential tremors, chronic pain due to failed back surgeries and other related neurological disorders about the benefits, administration

and use of our cortical strip, grid electrode and depth electrode technology and future versions;

● the prevalence and severity of adverse events, including, but not limited to, events related to the COVID-19

● the perceived advantages, cost, safety, convenience and accuracy of alternative therapies;

● obtaining and maintaining patent, trademark and trade secret protection and regulatory exclusivity for

our cortical strip, grid electrode and depth electrode technology and otherwise protecting our rights in our intellectual property portfolio;

● maintaining compliance with regulatory requirements, including current good manufacturing practices;

● obtaining and maintaining a continued acceptable performance and safety profile of our cortical strip,

grid electrode and depth electrode technology following approval.

The continuing development and commercialization

of our products depends upon us maintaining strong relationships with academic and healthcare institutions and professionals.

If we fail to maintain our strong working relationships

with healthcare and academic institutions and their professionals such as the Mayo Clinic, the Cleveland Clinic and Emory University,

many of our products may not be developed and marketed in line with the needs and expectations of the professionals who use and support

our products, which could cause a decline in our earnings and profitability.

The development, marketing and sales of many of our products

depends on our maintaining working relationships with healthcare institutions and professionals.

We rely on these professionals to provide

us with considerable knowledge and experience regarding the development, marketing and sale of our products.

If we are unable to maintain

strong relationships with these institutions and professionals, the development and marketing of our products could suffer, which could

have a material adverse effect on our business, results of operations, financial condition, and cash flows.

Our success depends on our ability

to continue to develop, commercialize and gain market acceptance for our cortical strip, grid electrode and depth electrode technology.

Our current business strategy is highly dependent

on developing and commercially launching our cortical strip, grid electrode and depth electrode technology, and achieving and maintaining

market acceptance.

In order for us to sell cortical strip, grid electrode and depth electrode technology to people with epilepsy, Parkinson’s

disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders, we must convince

them, their caregivers and healthcare providers that cortical strip, grid electrode and depth electrode technology is an attractive alternative

to competitive products for neuromodulation cEEG and sEEG recording, ablation, and brain stimulation.

Market acceptance and adoption of

our cortical strip, grid electrode and depth electrode technology depend on educating people with epilepsy, Parkinson’s disease,

dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders, as well as their caregivers

and healthcare providers, and other perceived benefits of our cortical strip, grid electrode and depth electrode technology as compared

to competitive products.

We may face challenges convincing physicians, many of whom have extensive experience with competitors’

products and established relationships with other companies, to appreciate the benefits of our cortical strip, grid electrode and depth

electrode technology and, in particular, our ability to successfully diagnose and treat epilepsy, Parkinson’s disease, dystonia,

essential tremors, chronic pain due to failed back surgeries and other related neurological disorders in a way that is superior to and

differentiated from currently available technology, and adopt it for treatment of their patients.

NeuroOne Medical Technologies Corporation

Achieving and maintaining market acceptance of

cortical strip, grid electrode and depth electrode technology could be negatively impacted by many factors, including:

● the failure of our cortical strip, grid electrode and depth electrode technology to achieve wide acceptance

among people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other

related neurological disorders, their caregivers, healthcare providers, third-party payors and key opinion leaders in the community;

● lack of evidence supporting the performance criteria or other perceived benefits of our cortical strip,

grid electrode and depth electrode technology over competitive products or other currently available technology;

● perceived risks associated with the use of our cortical strip, grid electrode and depth electrode technology

failure to successfully complete pre-clinical testing requirements required by the FDA;

may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial

contracts with third parties or clinical trial protocols with prospective trial sites, the

terms of which can be subject to extensive negotiation and may vary significantly among different

trials of our cortical strip, grid electrode and depth electrode technology may produce negative

or inconclusive results, including failure to demonstrate statistical significance, and we

may decide, or regulators may require us, to conduct additional clinical trials or abandon

our development programs;

number of people with brain related disorders required for clinical trials may be larger

than we anticipate, enrollment in these clinical trials may be slower than we anticipate

or people may drop out of these clinical trials or fail to return for post-treatment follow-up

at a higher rate than we anticipate;

Medical Technologies Corporation

products may have unanticipated adverse events, undesirable side effects or other unexpected

characteristics, causing us or our investigators, regulators or institutional review boards

to suspend or terminate the trials;

third-party contractors conducting the clinical trials may fail to comply with regulatory

requirements or meet their contractual obligations to us in a timely manner, or at all;

may require that we or our investigators suspend or terminate clinical development for various

reasons, including noncompliance with regulatory requirements or a finding that the participants

are being exposed to unacceptable health risks;

cost of clinical trials of our products may be greater than we anticipate;

supply or quality of our products or other materials necessary to conduct clinical trials

of our products may be insufficient or inadequate;

from our suppliers and manufacturers could impact clinical trial completion and impact revenue.

we are required to conduct additional clinical trials or other testing of our cortical strip, grid electrode and depth electrode technology

under development beyond those that we contemplate, if we are unable to successfully complete clinical trials, if the results of these

trials or tests are not favorable or if there are safety concerns, we may:

obtain marketing approval at all;

delayed in obtaining marketing approval for our cortical strip, grid electrode and depth

electrode technology under development in a jurisdiction;

subject to additional post-marketing testing requirements;

our cortical strip, grid electrode and depth electrode technology removed from the market

after obtaining marketing approval.

development costs will also increase if we experience delays in testing or marketing approvals.

We do not know whether any of our clinical

trials will begin as planned, will need to be restructured or will be completed on schedule, or at all.

Significant clinical trial delays

also could allow our competitors to bring innovative products to market before we do and impair our ability to successfully commercialize

our products.

if we obtain regulatory clearance and/or approval for all of our products, we will remain subject to extensive regulatory scrutiny and

compliance obligations.

before and after a product is commercially released, we will have ongoing responsibilities under FDA regulations.

We will also be subject

to periodic inspections by the FDA and comparable foreign authorities to determine compliance with regulatory requirements, such as the

Quality System Regulation, or QSR, of the FDA, medical device reporting regulations and regulations regarding notification, corrections,

These inspections can result in observations or reports, warning letters or other similar notices or forms of enforcement

If the FDA concludes that we are not in compliance with applicable laws or regulations, or that any of our products are ineffective

or pose an unreasonable health risk, it could ban these products, suspend or cancel our marketing authorizations, impose “stop-sale”

and “stop-import” orders, detain or seize adulterated or misbranded products, order a recall, repair, replacement, correction

or refund of such products, or require us to notify health providers and others that the products present unreasonable risks of substantial

harm to the public health.

Discovery of previously unknown problems with our product’s design or manufacture may result in restrictions

on use, restrictions placed on us or our suppliers, or withdrawal of an existing regulatory clearance.

The FDA may also impose operating

restrictions, enjoin and restrain certain violations of applicable law pertaining to medical devices, assess civil or criminal penalties

against our officers, employees or us, or recommend criminal prosecution of our Company.

Adverse regulatory action may restrict us from

effectively marketing and selling our products.

In addition, negative publicity and product liability claims resulting from any adverse

regulatory action could have a material adverse effect on our business, financial condition, and operating results.

Medical Technologies Corporation

addition, even though we have obtained FDA clearance to market two of our products, and even if we obtain the proper regulatory approval

or clearance to market any additional products under development, the FDA has the power to require us to conduct post-market surveillance

studies, which are designed to identify adverse events, device malfunctions or complaints from patients implanted with the device during

a specified period after the commencement of commercial use in the U.S.

The FDA may also require us to conduct post-approval studies

to further monitor the safety and/or effectiveness of our products.

Failure to conduct required surveillance or studies in a timely manner

could result in the revocation of the approved PMA product that is subject to such a requirement and could also result in the recall

or withdrawal of the product, which would prevent us from generating sales from that product in the United States.

may not be successful in commercializing our cortical strip, grid electrode and depth electrode.

anticipate that we will derive nearly all of our U.S.

revenue from the sales of our cortical strip, grid electrode and depth electrode

technology or future versions thereof.

we expect the revenue opportunity for additional uses of our technology to be greater than the technology and uses that have currently

been cleared by the FDA, and so we believe our ability to generate significant revenue in the future will be dependent upon the receipt

of additional FDA clearances.

revenue will be dependent, in part, upon the size of the markets in which we gain regulatory approval, the accepted price for the product,

the ability to obtain coverage and reimbursement, and whether we own the commercial rights for that territory.

If the number of people

we target is not as significant as we estimate or the treatment population is narrowed by competition, physician choice or treatment

guidelines, we may not generate significant revenue from sales of such products, even if approved.

success of any products that we develop will depend on several factors, including:

of timely commercialization approvals from applicable regulatory authorities;

ability to procure and maintain suppliers and manufacturers of the components of our current

cortical strip, grid electrode and depth electrode technology and future versions;

acceptance of our cortical strip, grid electrode and depth electrode technology by people

with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to

failed back surgeries and other related neurological disorders, the medical community and

third-party payors;

success in educating healthcare providers and people with epilepsy, Parkinson’s disease,

dystonia, essential tremors, chronic pain due to failed back surgeries and other related

neurological disorders about the benefits, administration and use of our cortical strip,

grid electrode and depth electrode technology and future versions;

prevalence and severity of adverse events and public health emergencies such as the COVID-19

perceived advantages, cost, safety, convenience and accuracy of alternative therapies;

and maintaining patent, trademark and trade secret protection and regulatory exclusivity

for our cortical strip, grid electrode and depth electrode technology and otherwise protecting

our rights in our intellectual property portfolio;

● maintaining

compliance with regulatory requirements, including current good manufacturing practices;

and maintaining a continued acceptable performance and safety profile of our cortical strip,

grid electrode and depth electrode technology.

Medical Technologies Corporation

continuing development and commercialization of our products depends upon us maintaining strong relationships with academic and healthcare

institutions and professionals.

we fail to maintain our strong working relationships with healthcare and academic institutions and their professionals such as the Mayo

Clinic, the Cleveland Clinic and Emory University, many of our products may not be developed and marketed in line with the needs and

expectations of the professionals who use and support our products, which could cause a decline in our earnings and profitability.

development, marketing and sales of many of our products depends on our maintaining working relationships with healthcare institutions

and professionals.

We rely on these professionals to provide us with considerable knowledge and experience regarding the development,

marketing and sale of our products.

If we are unable to maintain strong relationships with these institutions and professionals, the

development and marketing of our products could suffer, which could have a material adverse effect on our business, results of operations,

financial condition, and cash flows.

success depends on our ability to continue to develop, commercialize and gain market acceptance for our cortical strip, grid electrode

and depth electrode technology.

current business strategy is highly dependent on developing and commercially launching our cortical strip, grid electrode and depth electrode

technology, and achieving and maintaining market acceptance.

In order for us to sell cortical strip, grid electrode and depth electrode

technology to people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries

and other related neurological disorders, we must convince them, their caregivers and healthcare providers that cortical strip, grid

electrode and depth electrode technology is an attractive alternative to competitive products for neuromodulation cEEG and sEEG recording,

ablation, and brain stimulation.

Market acceptance and adoption of our cortical strip, grid electrode and depth electrode technology

depend on educating people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries

and other related neurological disorders, as well as their caregivers and healthcare providers, and other perceived benefits of our cortical

strip, grid electrode and depth electrode technology as compared to competitive products.

We may face challenges convincing physicians,

many of whom have extensive experience with competitors’ products and established relationships with other companies, to appreciate

the benefits of our cortical strip, grid electrode and depth electrode technology and, in particular, our ability to successfully diagnose

and treat epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related

neurological disorders in a way that is superior to and differentiated from currently available technology, and adopt it for treatment

of their patients.

and maintaining market acceptance of cortical strip, grid electrode and depth electrode technology could be negatively impacted by many

factors, including:

failure of our cortical strip, grid electrode and depth electrode technology to achieve wide

acceptance among people with epilepsy, Parkinson’s disease, dystonia, essential tremors,

chronic pain due to failed back surgeries and other related neurological disorders, their

caregivers, healthcare providers, third-party payors and key opinion leaders in the community;

of evidence supporting the performance criteria or other perceived benefits of our cortical

strip, grid electrode and depth electrode technology over competitive products or other currently

available technology;

risks associated with the use of our cortical strip, grid electrode and depth electrode technology

or similar products or technologies generally;

● the introduction of competitive products and the rate of acceptance of those products as compared to our

cortical strip, grid electrode and depth electrode technology;

● adverse results of clinical trials relating to our cortical strip, grid electrode and depth electrode

introduction of competitive products and the rate of acceptance of those products as compared

to our cortical strip, grid electrode and depth electrode technology;

Medical Technologies Corporation

results of clinical trials relating to our cortical strip, grid electrode and depth electrode

technology or similar competitive products;

● loss of regulatory clearance or approval for our cortical strip, grid electrode and depth electrode technology,

adverse publicity or other adverse events including any product liability lawsuits.

In addition, our cortical strip, grid electrode

and depth electrode technology may be perceived by people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic

pain due to failed back surgeries and other related neurological disorders, their caregivers or healthcare providers to be more complicated

or less effective than current technology, and people may be unwilling to change their current regimens.

Moreover, we believe that healthcare providers

tend to be slow to change their medical treatment practices because of perceived liability risks arising from the use of new products

and the uncertainty of third-party reimbursement.

Accordingly, healthcare providers may not recommend our cortical strip, grid electrode

and depth electrode technology until, if ever, there is sufficient evidence to convince them to alter the treatment methods they typically

recommend, such as receiving recommendations from prominent healthcare providers or other key opinion leaders in the community.

If we are not successful in convincing people

with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological

disorders of the benefits of our cortical strip, grid electrode and depth electrode technology, or if we are unable to achieve the support

of caregivers and healthcare providers or widespread market acceptance for our cortical strip, grid electrode and depth electrode technology,

then our sales potential, strategic objectives and profitability could be negatively impacted, which would adversely affect our business,

financial condition and operating results.

Failure to secure or retain coverage

or adequate reimbursement for our cortical strip, grid electrode and depth electrode technology or future versions thereof, including

the implantation procedures, by third-party payors could adversely affect our business, financial condition and operating results.

We plan to derive nearly all of our revenue from

sales of our cortical strip, grid electrode and depth electrode technology, in the United States and expect to do so for the next several

We anticipate a substantial portion of the purchase price of our cortical strip, grid electrode and depth electrode technology

will be paid for by third-party payors, including private insurance companies, preferred provider organizations and other managed care

Patients who receive treatment for their medical conditions and their healthcare providers generally rely on third-party payors

to reimburse all or part of the costs associated with their medical treatment, including healthcare providers’ services.

and adequate reimbursement from third-party payors, including governmental healthcare programs, such as Medicare and Medicaid, and commercial

payors, is critical to new product acceptance.

Future sales of our cortical strip, grid electrode and depth electrode technology will

be limited unless people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries

and other related neurological disorders can rely on third-party payors to pay for all or part of the cost to purchase our cortical strip,

grid electrode and depth electrode technology.

Access to adequate coverage and reimbursement for our cortical strip, grid electrode and

depth electrode technology by third-party payors is essential to the acceptance of our products by people with epilepsy, Parkinson’s

disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders.

NeuroOne Medical Technologies Corporation

In the United States, a third-party payor’s

decision to provide coverage for our products does not imply that an adequate reimbursement rate will be obtained.

Further, one third-party

payor’s decision to cover our products does not assure that other payors will also provide coverage for the products or will provide

coverage at an adequate reimbursement rate.

Healthcare providers may choose not to order a product unless third-party payors pay a substantial

portion of the product.

Within and outside the United States, reimbursement is obtained from a variety of sources, including government-sponsored

and private health insurance plans.

These third-party payors determine whether to provide coverage and reimbursement for specific products

and procedures.

Coverage determinations and reimbursement levels of both our products and the healthcare provider’s performance

of the insertion and removal procedures are critical to the commercial success of our product, and if we are not able to secure positive

coverage determinations and reimbursement levels for our products or the insertion and removal procedures, our business would be materially

adversely affected.

of regulatory clearance or approval for our cortical strip, grid electrode and depth electrode

technology, adverse publicity or other adverse events including any product liability lawsuits.

addition, our cortical strip, grid electrode and depth electrode technology may be perceived by people with epilepsy, Parkinson’s

disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders, their caregivers

or healthcare providers to be more complicated or less effective than current technology, and people may be unwilling to change their

current regimens.

we believe that healthcare providers tend to be slow to change their medical treatment practices because of perceived liability risks

arising from the use of new products and the uncertainty of third-party reimbursement.

Accordingly, healthcare providers may not recommend

our cortical strip, grid electrode and depth electrode technology until, if ever, there is sufficient evidence to convince them to alter

the treatment methods they typically recommend, such as receiving recommendations from prominent healthcare providers or other key opinion

leaders in the community.

we are not successful in convincing people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to

failed back surgeries and other related neurological disorders of the benefits of our cortical strip, grid electrode and depth electrode

technology, or if we are unable to achieve the support of caregivers and healthcare providers or widespread market acceptance for our

cortical strip, grid electrode and depth electrode technology, then our sales potential, strategic objectives and profitability could

be negatively impacted, which would adversely affect our business, financial condition and operating results.

to secure or retain coverage or adequate reimbursement for our cortical strip, grid electrode and depth electrode technology or future

versions thereof, including the implantation procedures, by third-party payors could adversely affect our business, financial condition

and operating results.

plan to derive nearly all of our revenue from sales of our cortical strip, grid electrode and depth electrode technology, in the United

States and expect to do so for the next several years.

We anticipate a substantial portion of the purchase price of our cortical strip,

grid electrode and depth electrode technology will be paid for by third-party payors, including private insurance companies, preferred

provider organizations and other managed care providers.

Patients who receive treatment for their medical conditions and their healthcare

providers generally rely on third-party payors to reimburse all or part of the costs associated with their medical treatment, including

healthcare providers’ services.

Coverage and adequate reimbursement from third-party payors, including governmental healthcare

programs, such as Medicare and Medicaid, and commercial payors, is critical to new product acceptance.

Future sales of our cortical strip,

grid electrode and depth electrode technology will be limited unless people with epilepsy, Parkinson’s disease, dystonia, essential

tremors, chronic pain due to failed back surgeries and other related neurological disorders can rely on third-party payors to pay for

all or part of the cost to purchase our cortical strip, grid electrode and depth electrode technology.

Access to adequate coverage and

reimbursement for our cortical strip, grid electrode and depth electrode technology by third-party payors is essential to the acceptance

of our products by people with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries

and other related neurological disorders.

the United States, a third-party payor’s decision to provide coverage for our products does not imply that an adequate reimbursement

rate will be obtained.

Further, one third-party payor’s decision to cover our products does not assure that other payors will also

provide coverage for the products or will provide coverage at an adequate reimbursement rate.

Healthcare providers may choose not to

order a product unless third-party payors pay a substantial portion of the product.

Within and outside the United States, reimbursement

is obtained from a variety of sources, including government-sponsored and private health insurance plans.

These third-party payors determine

whether to provide coverage and reimbursement for specific products and procedures.

Coverage determinations and reimbursement levels

of both our products and the healthcare provider’s performance of the insertion and removal procedures are critical to the commercial

success of our product, and if we are not able to secure positive coverage determinations and reimbursement levels for our products or

the insertion and removal procedures, our business would be materially adversely affected.

Medical Technologies Corporation

In addition, there may be significant delays in

32 unchanged sentences

available for our any product we develop, in the United States, the demand for our products and our revenues will be adversely affected.

NeuroOne Medical Technologies Corporation

Reimbursement by Medicare is highly

regulated and subject to change.

The Medicare program is administered by the Centers

Reimbursement by Medicare is highly regulated

and subject to change.

Medicare program is administered by the Centers

for Medicare and Medicaid Services, or CMS, which imposes extensive and detailed requirements on medical services providers, including,

3 unchanged sentences

monetary penalties, and/or criminal penalties, any of which could have a material adverse effect on our business and revenues.

If our competitors are better able

to develop and market products for the diagnosis and treatment of epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic

pain due to failed back surgeries and other related neurological disorders that are safer, more effective, less costly, easier to use

or otherwise more attractive than our cortical strip, grid electrode and depth electrode technology, our business will be adversely impacted.

If our competitors are better able to develop

and market products for the diagnosis and treatment of epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain

due to failed back surgeries and other related neurological disorders that are safer, more effective, less costly, easier to use or otherwise

more attractive than our cortical strip, grid electrode and depth electrode technology, our business will be adversely impacted.

The medical device industry is highly competitive

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product could have a material adverse effect on our business, financial condition and operating results.

Medical Technologies Corporation

In addition to facing competition from major competitors

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● greater name recognition;

● more established sales and marketing programs and distribution networks;

NeuroOne Medical Technologies Corporation

● earlier regulatory clearance or approval in the United States or foreign jurisdictions;

● more established sales and marketing programs and distribution

● earlier regulatory clearance or approval in the United States

or foreign jurisdictions;

● long established relationships with physicians and hospitals;

● significant patent portfolios, including issued U.S.

and foreign patents and pending patent applications,

as well as the resources to enforce patents against us or any of our third-party suppliers and distributors;

● the ability to acquire and integrate our competitors and/or their technology;

● demonstrated ability to develop product enhancements and new product offerings;

foreign patents and pending patent applications, as well as the resources to enforce patents against us or any of our third-party suppliers

and distributors;

● the ability to acquire and integrate our competitors and/or

their technology;

● demonstrated ability to develop product enhancements and

new product offerings;

● established history of product reliability, safety and durability;

● the ability to offer rebates or bundle multiple product offerings to offer greater discounts or incentives;

● greater financial and human resources for product development, sales, and marketing;

● greater experience in and resources for conducting research and development, clinical studies, manufacturing,

preparing regulatory submissions, obtaining regulatory clearance or approval for products and marketing approved products.

● the ability to offer rebates or bundle multiple product offerings

to offer greater discounts or incentives;

● greater financial and human resources for product development,

sales, and marketing;

● greater experience in and resources for conducting research

and development, clinical studies, manufacturing, preparing regulatory submissions, obtaining regulatory clearance or approval for products

and marketing approved products.

Our competitors may develop and patent processes

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than us in these matters, our business may be harmed.

The size and future growth in the

market for our cortical strip, grid electrode and depth electrode technology under development has not been established with precision

and may be smaller than we estimate, possibly materially.

If our estimates and projections overestimate the size of this market, our sales

growth may be adversely affected.

Medical Technologies Corporation

The size and future growth in the market

for our cortical strip, grid electrode and depth electrode technology has not been established with precision and may be smaller than

we estimate, possibly materially.

If our estimates and projections overestimate the size of this market, our sales growth may be adversely

Our estimates of the size and future growth in

the market for our cortical strip, grid electrode and depth electrode technology under development, including the number of people with

epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological

disorders who may benefit from and be amenable to using cortical strip, grid electrode and depth electrode technology for diagnosis and

treatment, is based on a number of internal and third-party studies, reports and estimates.

In addition, our internal estimates are based

in large part on current treatment patterns by healthcare providers using current generation technology and our belief is that the incidence

of epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological

disorders in the United States and worldwide is increasing.

While we believe these factors have historically provided and may continue

to provide us with effective tools in estimating the total market for cortical strip, grid electrode and depth electrode technology, these

estimates may not be correct and the conditions supporting our estimates may change at any time, thereby reducing the predictive accuracy

of these underlying factors.

The actual incidence of brain related disorders, and the actual demand for our products or competitive products,

could differ materially from our projections if our assumptions are incorrect.

As a result, our estimates of the size and future growth

in the market for cortical strip, grid electrode and depth electrode technology may prove to be incorrect.

If the actual number of people

with brain related disorders who would benefit from cortical strip, grid electrode and depth electrode technology and the size and future

growth in the market for cortical strip, grid electrode and depth electrode technology is smaller than we have estimated, it may impair

our projected sales growth and have an adverse impact on our business.

NeuroOne Medical Technologies Corporation

We depend on intellectual property

licensed from WARF for our technology, including our technology under development, and the termination of this license would harm our

the market for our cortical strip, grid electrode and depth electrode technology, including the number of people with epilepsy, Parkinson’s

disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders who may benefit

from and be amenable to using cortical strip, grid electrode and depth electrode technology for diagnosis and treatment, is based on a

number of internal and third-party studies, reports and estimates.

In addition, our internal estimates are based in large part on current

treatment patterns by healthcare providers using current generation technology and our belief is that the incidence of epilepsy, Parkinson’s

disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders in the United

States and worldwide is increasing.

While we believe these factors have historically provided and may continue to provide us with effective

tools in estimating the total market for cortical strip, grid electrode and depth electrode technology, these estimates may not be correct

and the conditions supporting our estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors.

The actual incidence of brain related disorders, and the actual demand for our products or competitive products, could differ materially

from our projections if our assumptions are incorrect.

As a result, our estimates of the size and future growth in the market for cortical

strip, grid electrode and depth electrode technology may prove to be incorrect.

If the actual number of people with brain related disorders

who would benefit from cortical strip, grid electrode and depth electrode technology and the size and future growth in the market for

cortical strip, grid electrode and depth electrode technology is smaller than we have estimated, it may impair our projected sales growth

and have an adverse impact on our business.

We depend on intellectual property licensed

from WARF for our technology, including our technology under development, and the termination of this license would harm our business.

WARF has granted us the WARF License, to make,

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waive future defaults or breaches or further amend the WARF License in the future, to the extent we request any waiver or amendment.

“Note 4-Commitments and Contingencies” included in “Item 8 - Financial Statements and Supplementary Data” in this

“Note 4 — Commitments and Contingencies” included in “Item 8 — Financial Statements and Supplementary

Data” in this Report.

Medical Technologies Corporation

Termination of our license could result in the

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our ability to develop and commercialize our cortical strip, grid electrode and depth electrode technology.

We depend on our partnership with

Mayo to license certain know how for the development and commercialization of our technology.

Termination of this partnership would harm

our business, and even if this partnership continues, it may not be successful.

We depend on our partnership with Mayo to

license certain know how for the development and commercialization of our technology.

Termination of this partnership would harm our business,

and even if this partnership continues, it may not be successful.

We have entered into the Mayo Development Agreement

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License and Development Agreement” for additional information regarding our agreement with Mayo.

NeuroOne Medical Technologies Corporation

The Mayo Development Agreement generally will

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ability to further develop our technology.

Medical Technologies Corporation

We depend on a limited number of third-party

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their ability to supply components or manufacture products for us, including financial difficulties, damage to their manufacturing equipment

or facilities, product discontinuations, or complications arising in connection with the COVID-19 pandemic.

or facilities, product discontinuations, or complications due to worldwide economic and social instability.

As a result, there is a risk

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if approved, limit our ability to meet our sales commitments, which could harm our reputation and adversely affect our business.

NeuroOne Medical Technologies Corporation

We may not procure volumes sufficient

to receive favorable pricing, which could impact our gross margins if we are unable to pass along price differences to our customers.

Recent global economic cost inflation trends could unfavorably impact pricing from our suppliers.

We may not procure volumes sufficient to receive

favorable pricing, which could impact our gross margins if we are unable to pass along price differences to our customers.

Recent global

economic cost inflation trends could unfavorably impact pricing from our suppliers.

Furthermore, vandalism, terrorism or a natural

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efforts and adversely affect our operating results.

See “-The COVID-19 pandemic has adversely

impacted, and may continue to impact, our business” above.

We contract with third parties for

the manufacture of our cortical strip, grid electrode and depth electrode technology, including our under development and expect to continue

to do so for clinical trials and commercialization.

Risks associated with the manufacturing of our products could reduce our gross margins

and negatively affect our operating results.

Medical Technologies Corporation

We contract with third parties for the manufacture

of our cortical strip, grid electrode and depth electrode technology, including our under development and expect to continue to do so

for clinical trials and commercialization.

Risks associated with the manufacturing of our products could reduce our gross margins and

negatively affect our operating results.

We currently rely, and expect to continue to rely,

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● quality or reliability defects;

● inability to secure product components in a timely manner, in sufficient quantities or on commercially

reasonable terms;

● inability to secure product components in a timely manner,

in sufficient quantities or on commercially reasonable terms;

● failure to increase production to meet demand;

● inability to modify production lines to enable us to efficiently produce future products or implement

changes in current products in response to regulatory requirements;

NeuroOne Medical Technologies Corporation

● difficulty identifying and qualifying alternative manufacturers in a timely manner;

● inability to modify production lines to enable us to efficiently

produce future products or implement changes in current products in response to regulatory requirements;

● difficulty identifying and qualifying alternative manufacturers

in a timely manner;

● inability to manufacture product components cost-effectively;

● inability to establish agreements with future third-party manufacturers or to do so on acceptable terms;

● potential damage to or destruction of our manufacturers’ equipment or facilities;

● failure to complete sterilization on time or in compliance with the required regulatory standards;

● inability to establish agreements with future third-party

manufacturers or to do so on acceptable terms;

● potential damage to or destruction of our manufacturers’

equipment or facilities;

● failure to complete sterilization on time or in compliance

with the required regulatory standards;

● transportation and import and export risk;

● delays in analytical results or failure of analytical techniques that we will depend on for quality control

and release of products;

● natural disasters, labor disputes, financial distress, raw material availability, issues with facilities

and equipment or other forms of disruption to business operations affecting our manufacturers or suppliers;

● latent defects that may become apparent after products have been released and that may result in a recall

of such products.

● delays in analytical results or failure of analytical techniques

that we will depend on for quality control and release of products;

● natural disasters, labor disputes, financial distress, raw

material availability, issues with facilities and equipment or other forms of disruption to business operations affecting our manufacturers

or suppliers;

● latent defects that may become apparent after products have

been released and that may result in a recall of such products.

These risks are likely to be exacerbated by our

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technology commercially viable.

Medical Technologies Corporation

Potential complications from our cortical

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We cannot assure you that use, even for a limited time, would not result in unanticipated complications, even after the device is removed.

Undetected errors or defects in our

cortical strip, grid electrode and depth electrode technology under development or future versions thereof could harm our reputation,

decrease the market acceptance of our cortical strip, grid electrode and depth electrode technology or expose us to product liability

claims adversely affecting our financial condition and results of operations or liquidity.

Undetected errors or defects in our cortical

strip, grid electrode and depth electrode technology under development or future versions thereof could harm our reputation, decrease

the market acceptance of our cortical strip, grid electrode and depth electrode technology or expose us to product liability claims adversely

affecting our financial condition and results of operations or liquidity.

Our cortical strip, grid electrode and depth electrode

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been subject to extensive litigation over product liability claims, and we cannot offer any assurance that we will not face product liability

NeuroOne Medical Technologies Corporation

Our clinical and commercial product liability insurance coverage may not be sufficient to cover claims that may be made against

In addition, we may not be able to maintain insurance coverage at a reasonable cost, or in sufficient amounts or scope, to protect

us against losses.

Any claims against us, regardless of their merit, could severely harm our financial condition, strain our management

team and other resources, and adversely impact or eliminate the prospects for commercialization of the product candidate, or sale of the

product, which that is the subject of any such claim.

The sale and use of our cortical strip, grid electrode

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● the inability to commercialize our cortical strip, grid electrode and depth electrode technology;

Medical Technologies Corporation

● decreased demand;

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future on terms acceptable to us or at all.

We depend on sophisticated information

technology systems, and any breach or disruption affecting these systems could adversely affect our business, financial condition and

operating results.

We depend on sophisticated information technology

systems, and any breach or disruption affecting these systems could adversely affect our business, financial condition and operating results.

The efficient operation of our business depends

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disasters, terrorist attacks, attacks by computer viruses or hackers, power losses, and computer system or data network failures.

NeuroOne Medical Technologies Corporation

In addition, our data management application and

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operating results.

Zimmer has exclusive global rights

to distribute our strip and grid cortical electrodes and electrode cable assembly products.

Zimmer’s failure to timely develop or

commercialize these products would have a material adverse effect on our business and operating results.

Further, our inability to agree

with Zimmer on dates of completion for product development, regulatory clearance and commercialization milestones on which various fee

payments to the Company are based under the Zimmer Development Agreement could have a material adverse impact on our financial and operating

Medical Technologies Corporation

Zimmer has exclusive global rights to distribute

our strip and grid cortical electrodes and electrode cable assembly products.

Zimmer’s failure to timely develop or commercialize

these products would have a material adverse effect on our business and operating results.

Further, our inability to agree with Zimmer

on dates of completion for product development, regulatory clearance and commercialization milestones on which various fee payments to

the Company are based under the Zimmer Development Agreement could have a material adverse impact on our financial and operating results.

The Company granted Zimmer an exclusive global

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successful due to several factors, including the following:

● Zimmer may not be able to obtain from us or manufacture our products in a timely or cost-effective manner;

● Zimmer may not timely perform its obligations under the Zimmer Development Agreement;

● Zimmer may not be able to obtain from us or manufacture our

products in a timely or cost-effective manner;

● Zimmer may not timely perform its obligations under the Zimmer

Development Agreement;

● Zimmer may fail to effectively commercialize our products;

● contractual disputes or other disagreements between us and Zimmer, including those regarding the development,

manufacture, and commercialization of our products, interpretation of the Zimmer Development Agreement, and ownership of proprietary rights.

● contractual disputes or other disagreements between us and

Zimmer, including those regarding the development, manufacture, and commercialization of our products, interpretation of the Zimmer Development

Agreement, and ownership of proprietary rights.

Any of the foregoing could adversely impact the

likelihood and timing of any payments we are eligible to receive under the Zimmer Development Agreement.

FDA clearance is one condition

of the Product Availability Date.

The Company is reliant on Zimmer to drive the commercialization and sales of our products.

does not perform its obligations under the Zimmer Development Agreement, we may be forced to incur material expenses to build a sales

organization and infrastructure to market our products which sales would be substantially delayed and could result in a material adverse

effect on our business, results of operations and prospects and would likely cause our stock price to decline.

We have entered into, and may enter

into additional collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships with third-parties that

may not result in the development of commercially viable products or the generation of significant future revenues.

The Company is reliant on Zimmer

to drive the commercialization and sales of our products.

If Zimmer does not perform its obligations under the Zimmer Development Agreement,

we may be forced to incur material expenses to build a sales organization and infrastructure to market our products which sales would

be substantially delayed and could result in a material adverse effect on our business, results of operations and prospects and would

likely cause our stock price to decline.

We have entered into, and may enter into

additional collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships with third-parties that may

not result in the development of commercially viable products or the generation of significant future revenues.

In the ordinary course of our business, we may

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any products.

Additionally, we may not be in a position to exercise

sole decision making authority regarding the transaction or arrangement, which could create the potential risk of creating impasses on

decisions, and our future collaborators may have economic or business interests or goals that are, or that may become, inconsistent with

our business interests or goals.

It is possible that conflicts may arise with our collaborators, such as conflicts concerning the achievement

of performance milestones, or the interpretation of significant terms under any agreement, such as those related to financial obligations

or the ownership or control of intellectual property developed during the collaboration.

If any conflicts arise with any future collaborators,

they may act in their self-interest, which may be adverse to our best interest, and they may breach their obligations to us.

we may have limited control over the amount and timing of resources that any future collaborators devote to our or their future products.

Disputes between us and our collaborators may result in litigation or arbitration which would increase our expenses and divert the attention

of our management.

Further, these transactions and arrangements will be contractual in nature and will generally be terminable under the

terms of the applicable agreements and, in such event, we may not continue to have rights to the products relating to such transaction

or arrangement or may need to purchase such rights at a premium.

Medical Technologies Corporation

Additionally,

we may not be in a position to exercise sole decision making authority regarding the transaction or arrangement, which could create the

potential risk of creating impasses on decisions, and our future collaborators may have economic or business interests or goals that

are, or that may become, inconsistent with our business interests or goals.

It is possible that conflicts may arise with our collaborators,

such as conflicts concerning the achievement of performance milestones, or the interpretation of significant terms under any agreement,

such as those related to financial obligations or the ownership or control of intellectual property developed during the collaboration.

If any conflicts arise with any future collaborators, they may act in their self-interest, which may be adverse to our best interest,

and they may breach their obligations to us.

In addition, we may have limited control over the amount and timing of resources that any

future collaborators devote to our or their future products.

Disputes between us and our collaborators may result in litigation or arbitration

which would increase our expenses and divert the attention of our management.

Further, these transactions and arrangements will be contractual

in nature and will generally be terminable under the terms of the applicable agreements and, in such event, we may not continue to have

rights to the products relating to such transaction or arrangement or may need to purchase such rights at a premium.

we enter into in-bound intellectual property license agreements, we may not be able to fully protect the licensed intellectual property

rights or maintain those licenses.

Future licensors could retain the right to prosecute and defend the intellectual property rights licensed

to us, in which case we would depend on the ability of our licensors to obtain, maintain and enforce intellectual property protection

for the licensed intellectual property.

These licensors may determine not to pursue litigation against other companies or may pursue

such litigation less aggressively than we would.

Further, entering into such license agreements could impose various diligence, commercialization,

royalty or other obligations on us.

Future licensors may allege that we have breached our license agreement with them, and accordingly

seek to terminate our license, which could adversely affect our competitive business position and harm our business prospects.

Related to our Intellectual Property

ability to protect our intellectual property and proprietary technology is uncertain.

medical device market in which we operate is largely technology driven.

We rely primarily on patent, trademark and trade secret laws,

as well as confidentiality and non-disclosure agreements, to protect our intellectual property and proprietary technologies.

to review new technological developments in order to make decisions about what additional filings would be the most appropriate for us.

We also plan to seek patent protection for our proprietary technology in select countries internationally.

If we fail to timely file

a patent application in any jurisdiction, we may be precluded from doing so at a later date.

Furthermore, we cannot assure you that any

patent application will be approved in a timely manner or at all.

The rights granted to us under our patents, and the rights we are seeking

to have granted in our pending patent applications, may not be meaningful or provide us with any commercial advantage.

In addition, those

rights could be opposed, contested or circumvented by our competitors, or be declared invalid or unenforceable in judicial or administrative

The failure of our patents to adequately protect our technology might make it easier for our competitors to offer the same

or similar products or technologies.

Even if we are successful in receiving patent protection for certain products and processes, our

competitors may be able to design around our patents or develop products that provide outcomes which are comparable to ours without infringing

on our intellectual property rights.

Due to differences between foreign and U.S.

patent laws, our patented intellectual property rights

may not receive the same degree of protection in foreign countries as they would in the United States.

Even if patents are granted outside

the United States, effective enforcement in those countries may not be available.

rely on our trademarks and trade names to distinguish our products from the products of our competitors, and have registered or

applied to register many of these trademarks.

For example, we have a registered U.S.

If we enter into in-bound intellectual property

license agreements, we may not be able to fully protect the licensed intellectual property rights or maintain those licenses.

Future licensors

could retain the right to prosecute and defend the intellectual property rights licensed to us, in which case we would depend on the ability

of our licensors to obtain, maintain and enforce intellectual property protection for the licensed intellectual property.

These licensors

may determine not to pursue litigation against other companies or may pursue such litigation less aggressively than we would.

entering into such license agreements could impose various diligence, commercialization, royalty or other obligations on us.

Future licensors

may allege that we have breached our license agreement with them, and accordingly seek to terminate our license, which could adversely

affect our competitive business position and harm our business prospects.

We have been the victim of a cyber-related

crime and our controls may not be successful in avoiding further cyber-related crimes in the future.

In January 2023, we were the victim of a business

email compromise fraud which resulted in our incurring a loss of approximately $0.1 million.

We have worked with law enforcement authorities

and the banks involved in the wire transfer to pursue recovery of the $0.1 million, but at this time we do not expect that we will be

able to recover such funds.

Enhancements have been made to our controls relating to electronic payments by or for us that we believe will

reduce our risk of becoming a victim of future frauds related to our payments, including by wire transfers.

However, cyber-related criminal

activities continue to evolve and increase in sophistication, frequency and severity.

As a result, the control enhancements that have

been made, and any additional enhancements that may be made in the future, to our controls may not be successful in avoiding our becoming

a victim to further cyber-related crimes.

Risks Related to our Intellectual Property

Our ability to protect our intellectual

property and proprietary technology is uncertain.

The medical device market in which we operate

is largely technology driven.

We rely primarily on patent, trademark and trade secret laws, as well as confidentiality and non-disclosure

agreements, to protect our intellectual property and proprietary technologies.

We continue to review new technological developments in

order to make decisions about what additional filings would be the most appropriate for us.

We also plan to seek patent protection for

our proprietary technology in select countries internationally.

If we fail to timely file a patent application in any jurisdiction, we

may be precluded from doing so at a later date.

Furthermore, we cannot assure you that any patent application will be approved in a timely

manner or at all.

The rights granted to us under our patents, and the rights we are seeking to have granted in our pending patent applications,

may not be meaningful or provide us with any commercial advantage.

In addition, those rights could be opposed, contested or circumvented

by our competitors, or be declared invalid or unenforceable in judicial or administrative proceedings.

The failure of our patents to adequately

protect our technology might make it easier for our competitors to offer the same or similar products or technologies.

Even if we are

successful in receiving patent protection for certain products and processes, our competitors may be able to design around our patents

or develop products that provide outcomes which are comparable to ours without infringing our intellectual property rights.

Due to differences

between foreign and U.S.

patent laws, our patented intellectual property rights may not receive the same degree of protection in foreign

countries as they would in the United States.

Even if patents are granted outside the United States, effective enforcement in those countries

may not be available.

We rely on our trademarks and trade names to distinguish

our products from the products of our competitors, and have registered or applied to register many of these trademarks.

For example, we

have a registered U.S.

trademark for the “EVO” trademark.

We cannot assure you that our trademark applications will be approved in a timely manner or at all.

Third parties also may oppose

our trademark applications, or otherwise challenge our use of the trademarks.

In the event that our trademarks are successfully

challenged, we could be forced to rebrand our products, which could result in loss of brand recognition, and could require us to

devote additional resources to marketing new brands.

Further, we cannot assure you that competitors will not infringe upon our

trademarks, or that we will have adequate resources to enforce our trademarks.

We cannot assure you that our trademark applications will be approved

in a timely manner or at all.

Third parties also may oppose our trademark applications, or otherwise challenge our use of the trademarks.

In the event that our trademarks are successfully challenged, we could be forced to rebrand our products, which could result in loss of

brand recognition, and could require us to devote additional resources to marketing new brands.

Further, we cannot assure you that competitors

will not infringe upon our trademarks, or that we will have adequate resources to enforce our trademarks.

Medical Technologies Corporation

also rely on trade secrets, know-how and technology, which are not protectable by patents, to maintain our competitive position.

to protect this information by entering into confidentiality agreements and intellectual property assignment agreements with our officers,

employees, temporary employees and consultants regarding our intellectual property and proprietary technology.

In the event of unauthorized

use or disclosure or other breaches of those agreements, we may not be provided with meaningful protection for our trade secrets or other

proprietary information.

In addition, our trade secrets may otherwise become known or be independently discovered by competitors.

the extent that our commercial partners, collaborators, employees and consultants use intellectual property owned by others in their

work for us, disputes may arise as to the rights in the related or resulting know-how and inventions.

If any of our trade secrets, know-how

or other technologies not protected by a patent were to be disclosed to or independently developed by a competitor, our business, financial

condition and results of operations could be materially adversely affected.

a competitor infringes upon one of our patents, trademarks or other intellectual property rights, enforcing those patents, trademarks

and other rights may be difficult and time-consuming.

Patent law relating to the scope of claims in the industry in which we operate

is subject to rapid change and constant evolution and, consequently, patent positions in our industry can be uncertain.

Even if successful,

litigation to defend our patents and trademarks against challenges or to enforce our intellectual property rights could be expensive

and time consuming and could divert management’s attention from managing our business.

Moreover, we may not have sufficient resources

or desire to defend our patents or trademarks against challenges or to enforce our intellectual property rights.

Litigation also puts

our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing.

Additionally, we

may provoke third-parties to assert claims against us.

We may not prevail in any lawsuits that we initiate and the damages or other remedies

awarded, if any, may not be commercially valuable.

The occurrence of any of these events may harm our business, financial condition and

operating results.

is limited market awareness of our technology, and we may not be able to establish or strengthen our brand.

is currently limited market awareness of our technology.

We believe that establishing and strengthening our brand is critical to achieving

widespread acceptance of our cortical strip, grid electrode and depth electrode technology.

Promoting and positioning our brand, and

increasing market awareness of our technology, will depend largely on the success of our marketing efforts and our ability to provide

physicians with a reliable product for successful treatment of brain-related disorders.

Additionally, we believe the quality and reliability

of our product is critical to building physician support in the United States, and any negative publicity regarding the quality or reliability

of our cortical strip, grid electrode and depth electrode technology could significantly damage our reputation in the market.

given the established nature of our competitors, it is likely that our future marketing efforts will require us to incur significant

additional expenses.

These brand promotion activities may not yield increased sales and, even if they do, any sales increases may not

offset the expenses we incur to promote our brand.

If we fail to successfully promote and maintain our brand, or if we incur substantial

expenses in an unsuccessful attempt to promote and maintain our brand, our cortical strip, grid electrode and depth electrode technology

may not be accepted by physicians, which would adversely affect our business, results of operations and financial condition.

could become subject to patent litigation that could be costly, result in the diversion of management’s time and efforts, stop

our development and commercialization measures or require us to pay damages.

success will depend in part on not infringing the patents or violating the other proprietary rights of third-parties.

Significant litigation

regarding patent rights exists in our industry.

Our competitors in both the United States and abroad, many of which have substantially

greater resources and have made substantial investments in competing technologies, may have applied for or obtained or may in the future

apply for and obtain, patents that will prevent, limit or otherwise interfere with our ability to make and sell our products.

number of patents, the rapid rate of new patent issuances, and the complexities of the technology involved increase the risk of patent

We also rely on trade secrets, know-how and technology,

which are not protectable by patents, to maintain our competitive position.

We try to protect this information by entering into confidentiality

agreements and intellectual property assignment agreements with our officers, employees, temporary employees and consultants regarding

our intellectual property and proprietary technology.

In the event of unauthorized use or disclosure or other breaches of those agreements,

we may not be provided with meaningful protection for our trade secrets or other proprietary information.

In addition, our trade secrets

may otherwise become known or be independently discovered by competitors.

To the extent that our commercial partners, collaborators, employees

and consultants use intellectual property owned by others in their work for us, disputes may arise as to the rights in the related or

resulting know-how and inventions.

If any of our trade secrets, know-how or other technologies not protected by a patent were to be disclosed

to or independently developed by a competitor, our business, financial condition and results of operations could be materially adversely

If a competitor infringes upon one of our patents,

trademarks or other intellectual property rights, enforcing those patents, trademarks and other rights may be difficult and time-consuming.

Patent law relating to the scope of claims in the industry in which we operate is subject to rapid change and constant evolution and,

consequently, patent positions in our industry can be uncertain.

Even if successful, litigation to defend our patents and trademarks against

challenges or to enforce our intellectual property rights could be expensive and time consuming and could divert management’s attention

from managing our business.

Moreover, we may not have sufficient resources or desire to defend our patents or trademarks against challenges

or to enforce our intellectual property rights.

Litigation also puts our patents at risk of being invalidated or interpreted narrowly

and our patent applications at risk of not issuing.

Additionally, we may provoke third-parties to assert claims against us.

prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially valuable.

The occurrence

of any of these events may harm our business, financial condition and operating results.

There is limited market awareness of our

technology, and we may not be able to establish or strengthen our brand.

There is currently limited market awareness of

our technology.

We believe that establishing and strengthening our brand is critical to achieving widespread acceptance of our cortical

strip, grid electrode and depth electrode technology.

Promoting and positioning our brand, and increasing market awareness of our technology,

will depend largely on the success of our marketing efforts and our ability to provide physicians with a reliable product for successful

treatment of brain-related disorders.

Additionally, we believe the quality and reliability of our product is critical to building physician

support in the United States, and any negative publicity regarding the quality or reliability of our cortical strip, grid electrode and

depth electrode technology could significantly damage our reputation in the market.

Further, given the established nature of our competitors,

it is likely that our future marketing efforts will require us to incur significant additional expenses.

These brand promotion activities

may not yield increased sales and, even if they do, any sales increases may not offset the expenses we incur to promote our brand.

we fail to successfully promote and maintain our brand, or if we incur substantial expenses in an unsuccessful attempt to promote and

maintain our brand, our cortical strip, grid electrode and depth electrode technology may not be accepted by physicians, which would adversely

affect our business, results of operations and financial condition.

We could become subject to patent litigation

that could be costly, result in the diversion of management’s time and efforts, stop our development and commercialization measures

or require us to pay damages.

Our success will depend in part on not infringing

the patents or violating the other proprietary rights of third-parties.

Significant litigation regarding patent rights exists in our industry.

Our competitors in both the United States and abroad, many of which have substantially greater resources and have made substantial investments

in competing technologies, may have applied for or obtained or may in the future apply for and obtain, patents that will prevent, limit

or otherwise interfere with our ability to make and sell our products.

The large number of patents, the rapid rate of new patent issuances,

and the complexities of the technology involved increase the risk of patent litigation.

In the future, we could receive communications

from various industry participants alleging our infringement of their intellectual property rights.

Any potential intellectual property

litigation could force us to do one or more of the following:

● stop selling our products or using technology that contains

the allegedly infringing intellectual property;

● incur significant legal expenses;

Medical Technologies Corporation

the future, we could receive communications from various industry participants alleging our infringement of their intellectual property

Any potential intellectual property litigation could force us to do one or more of the following:

selling our products or using technology that contains the allegedly infringing intellectual

significant legal expenses;

substantial damages to the party whose intellectual property rights we are allegedly infringing;

those products that contain the allegedly infringing intellectual property;

to obtain a license to the relevant intellectual property from third-parties, which may not

be available on reasonable terms or at all, and if available, may be non-exclusive, thereby

● pay substantial damages to the party whose intellectual property

rights we are allegedly infringing;

● redesign those products that contain the allegedly infringing

intellectual property;

● attempt to obtain a license to the relevant intellectual

property from third-parties, which may not be available on reasonable terms or at all, and if available, may be non-exclusive, thereby

giving our competitors access to the same technology.

litigation can involve complex factual and legal questions, and its outcome is uncertain.

Any litigation or claim against us, even those

without merit, may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention

of management from our core business and harm our reputation.

Further, as the number of participants in the neurostimulation market increases,

the possibility of intellectual property infringement claims against us increases.

may be subject to damages resulting from claims that we, or our employees, have wrongfully used or disclosed alleged trade secrets of

our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.

of our current or future employees may have previously been employed at other medical device companies, including those that are our

direct competitors or could potentially be our direct competitors.

We may be subject to claims that we, or our employees, have inadvertently

or otherwise used or disclosed trade secrets or other proprietary information of these former employers or competitors.

we may in the future be subject to allegations that we caused an employee to breach the terms of his or her non-competition or non-solicitation

Litigation may be necessary to defend against these claims.

are currently subject to litigation with the former employer of a current employee of NeuroOne, which is described in more detail under

“Note 4-Commitments and Contingencies” included in “Item 8 - Financial Statements and Supplementary Data” in

this Annual Report .

if we successfully defend against these claims, litigation could result in substantial costs place a significant strain on our financial

resources, divert the attention of management from our core business and harm our reputation.

If our defense to those claims fails, in

addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.

There can be no assurance that this

type of litigation will not occur, and any future litigation or the threat thereof may adversely affect our ability to hire additional

A loss of key personnel or their work product could hamper or prevent our ability to commercialize our cortical strip, grid

electrode and depth electrode technology or future versions thereof, which could have an adverse effect on our business, financial condition

and operating results.

property rights do not necessarily address all potential threats to our competitive advantage.

degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations,

and may not adequately protect our business, or permit us to maintain our competitive advantage.

Patent litigation can involve complex factual

and legal questions, and its outcome is uncertain.

Any litigation or claim against us, even those without merit, may cause us to incur

substantial costs, and could place a significant strain on our financial resources, divert the attention of management from our core business

and harm our reputation.

Further, as the number of participants in the neurostimulation market increases, the possibility of intellectual

property infringement claims against us increases.

We may be subject to damages resulting from

claims that we, or our employees, have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition

or non-solicitation agreements with our competitors.

Some of our current or future employees may have

previously been employed at other medical device companies, including those that are our direct competitors or could potentially be our

direct competitors.

We may be subject to claims that we, or our employees, have inadvertently or otherwise used or disclosed trade secrets

or other proprietary information of these former employers or competitors.

In addition, we may in the future be subject to allegations

that we caused an employee to breach the terms of his or her non-competition or non-solicitation agreement.

Litigation may be necessary

to defend against these claims.

There can be no assurance that this type of litigation

will not occur, and any future litigation or the threat thereof may adversely affect our ability to hire additional employees.

of key personnel or their work product could hamper or prevent our ability to commercialize our cortical strip, grid electrode and depth

electrode technology or future versions thereof, which could have an adverse effect on our business, financial condition and operating

Intellectual property rights do not necessarily

address all potential threats to our competitive advantage.

The degree of future protection afforded by our

intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business,

or permit us to maintain our competitive advantage.

The following examples are illustrative:

may be able to make devices that are the same as or similar to our cortical strip, grid electrode

and depth electrode technology but that are not covered by the claims of the patents that

Medical Technologies Corporation

or any collaborators might not have been the first to make the inventions covered by the

issued patents or pending patent applications that we own;

might not have been the first to file patent applications covering certain of our inventions;

may independently develop similar or alternative technologies or duplicate any of our technologies

without infringing our intellectual property rights;

is possible that our pending patent applications will not lead to issued patents;

patents that we own may not provide us with any competitive advantages, or may be held invalid

or unenforceable as a result of legal challenges;

might enforce our patent rights or defend a challenge to our issued patents or pending application,

putting the patents and patent applications at risk of being invalidated or interpreted narrowly;

competitors might conduct research and development activities in the United States and other

countries that provide a safe harbor from patent infringement claims for certain research

and development activities, as well as in countries where we do not have patent rights, and

then use the information learned from such activities to develop competitive products for

sale in our major commercial markets;

may not develop additional proprietary technologies that are patentable.

Related to our Legal and Regulatory Environment

products and operations are subject to extensive governmental regulation, and any adverse regulatory action may materially adversely

affect our financial condition and business operations.

medical devices and technologies and business activities, including marketing, manufacturing, sales and development processes, are subject

to regulation by the FDA, U.S.

Department of Justice, Health and Human Services - Office of Inspector General, and other federal and

state, governmental authorities.

These governmental authorities enforce laws and regulations that are meant to assure product safety

and effectiveness, including the regulation of, among other things:

design and development;

● pre-clinical

studies and clinical trials;

● establishment

registration and product listing;

content and language of instructions for use and storage;

manufacturing, sales and distribution;

clearance or approval;

and post-market surveillance;

● record-keeping

import and export;

● others may be able to make devices that are the same as or

similar to our cortical strip, grid electrode and depth electrode technology but that are not covered by the claims of the patents that

● we or any collaborators might not have been the first to

make the inventions covered by the issued patents or pending patent applications that we own;

● we might not have been the first to file patent applications

covering certain of our inventions;

● others may independently develop similar or alternative technologies

or duplicate any of our technologies without infringing our intellectual property rights;

● it is possible that our pending patent applications will

not lead to issued patents;

● issued patents that we own may not provide us with any competitive

advantages, or may be held invalid or unenforceable as a result of legal challenges;

● we might enforce our patent rights or defend a challenge

to our issued patents or pending application, putting the patents and patent applications at risk of being invalidated or interpreted

● our competitors might conduct research and development activities

in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development

activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to

develop competitive products for sale in our major commercial markets;

● we may not develop additional proprietary technologies that

are patentable.

Medical Technologies Corporation

● advertising

and promotion;

and field safety corrective actions.

regulations to which we are subject are complex and have tended to become more stringent over time.

Regulatory changes could result in

restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated revenues.

to comply with applicable regulations could jeopardize our ability to sell our products and result in enforcement actions such as fines,

civil penalties, injunctions, warning letters, recalls of products, delays in the introduction of products into the market, refusal of

the regulatory agency or other regulators to grant future clearances or approvals, and the suspension or withdrawal of existing approvals

by such regulatory agencies.

Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and

harm our reputation, business, financial condition and operating results.

recall of our products, or the discovery of serious safety issues with our products, could have a significant negative impact on us.

FDA has the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or

manufacture or in the event that a product poses an unacceptable risk to health.

Our third-party suppliers may, under their own initiative,

recall a product if any material deficiency in a device is found.

A government-mandated or voluntary recall by us or one of our third-party

distributors, if any, could occur as a result of an unacceptable risk to health, component failures, manufacturing errors, design or

labeling defects or other deficiencies and issues.

Recalls of any of our products would divert managerial and financial resources and

have an adverse effect on our reputation, financial condition and operating results, which could impair our ability to produce our products

in a cost-effective and timely manner.

under the FDA’s medical device reporting regulations, we are required to report to the FDA any incident in which our product may

have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction were to recur,

would likely cause or contribute to death or serious injury.

Repeated product malfunctions may result in a voluntary or involuntary product

recall, which could divert managerial and financial resources, impair our ability to manufacture our products in a cost-effective and

timely manner and have an adverse effect on our reputation, financial condition and operating results.

adverse event involving our products could result in future voluntary corrective actions, such as recalls or customer notifications,

or regulatory agency action, which could include inspection, mandatory recall or other enforcement action.

Any corrective action, whether

voluntary or involuntary, will require the dedication of our time and capital, distract management from operating our business and may

harm our reputation and financial results.

are subject to additional federal, state and foreign laws and regulations relating to our healthcare business;

our failure to comply

with those laws could have an adverse impact on our business.

we will not provide healthcare services, submit claims for third-party reimbursement, or receive payments directly from government health

insurance programs or other third-party payors for our cortical strip, grid electrode and depth electrode technology, we are subject

to healthcare fraud and abuse regulation and enforcement by federal, state and foreign governments, which could adversely impact our

Healthcare fraud and abuse and health information privacy and security laws potentially applicable to our operations include,

but are not limited to:

Anti-Kickback Statute, which will apply to our marketing practices, educational programs,

pricing policies and relationships with healthcare providers, by prohibiting, among other

things, soliciting, receiving, offering or providing remuneration intended to induce the

purchase or recommendation of an item or service reimbursable under a federal healthcare

program, such as the Medicare or Medicaid programs.

A person or entity does not need to have

actual knowledge of this statute or specific intent to violate it to have committed a violation;

Risks Related to our Legal and Regulatory Environment

Our products and operations are subject

to extensive governmental regulation, and any adverse regulatory action may materially adversely affect our financial condition and business

Our medical devices and technologies and business

activities, including marketing, manufacturing, sales and development processes, are subject to regulation by the FDA, U.S.

of Justice, Health and Human Services - Office of Inspector General, and other federal and state, governmental authorities.

These governmental

authorities enforce laws and regulations that are meant to assure product safety and effectiveness, including the regulation of, among

other things:

● product design and development;

● pre-clinical studies and clinical trials;

● product safety;

● establishment registration and product listing;

● labeling, content and language of instructions for use and

● marketing, manufacturing, sales and distribution;

● pre-market clearance or approval;

● servicing and post-market surveillance;

● record-keeping procedures;

● product import and export;

● advertising and promotion;

● recalls and field safety corrective actions.

The regulations to which we are subject are complex

and have tended to become more stringent over time.

Regulatory changes could result in restrictions on our ability to carry on or expand

our operations, higher than anticipated costs or lower than anticipated revenues.

Failure to comply with applicable regulations

could jeopardize our ability to sell our products and result in enforcement actions such as fines, civil penalties, injunctions, warning

letters, recalls of products, delays in the introduction of products into the market, refusal of the regulatory agency or other regulators

to grant future clearances or approvals, and the suspension or withdrawal of existing approvals by such regulatory agencies.

sanctions could result in higher than anticipated costs or lower than anticipated sales and harm our reputation, business, financial condition

and operating results.

A recall of our products, or the discovery

of serious safety issues with our products, could have a significant negative impact on us.

The FDA has the authority to require the recall

of commercialized products in the event of material deficiencies or defects in design or manufacture or in the event that a product poses

an unacceptable risk to health.

Our third-party suppliers may, under their own initiative, recall a product if any material deficiency

in a device is found.

A government-mandated or voluntary recall by us or one of our third-party distributors, if any, could occur as a

result of an unacceptable risk to health, component failures, manufacturing errors, design or labeling defects or other deficiencies and

Recalls of any of our products would divert managerial and financial resources and have an adverse effect on our reputation, financial

condition and operating results, which could impair our ability to produce our products in a cost-effective and timely manner.

Medical Technologies Corporation

civil and criminal false claims laws and civil monetary penalty laws, including civil whistleblower

or qui tam actions that prohibit, among other things, knowingly presenting, or causing to

be presented, claims for payment or approval to the federal government that are false or

fraudulent, knowingly making a false statement material to an obligation to pay or transmit

money or property to the federal government or knowingly concealing or knowingly and improperly

avoiding or decreasing an obligation to pay or transmit money or property to the federal

The government may assert that a claim including items or services resulting

from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for

Further, under the FDA’s medical device

reporting regulations, we are required to report to the FDA any incident in which our product may have caused or contributed to a death

or serious injury or in which our product malfunctioned and, if the malfunction were to recur, would likely cause or contribute to death

or serious injury.

Repeated product malfunctions may result in a voluntary or involuntary product recall, which could divert managerial

and financial resources, impair our ability to manufacture our products in a cost-effective and timely manner and have an adverse effect

on our reputation, financial condition and operating results.

Any adverse event involving our products could

result in future voluntary corrective actions, such as recalls or customer notifications, or regulatory agency action, which could include

inspection, mandatory recall or other enforcement action.

Any corrective action, whether voluntary or involuntary, will require the dedication

of our time and capital, distract management from operating our business and may harm our reputation and financial results.

We are subject to additional federal, state

and foreign laws and regulations relating to our healthcare business;

our failure to comply with those laws could have an adverse impact

on our business.

Although we will not provide healthcare services,

submit claims for third-party reimbursement, or receive payments directly from government health insurance programs or other third-party

payors for our cortical strip, grid electrode and depth electrode technology, we are subject to healthcare fraud and abuse regulation

and enforcement by federal, state and foreign governments, which could adversely impact our business.

Healthcare fraud and abuse and health

information privacy and security laws potentially applicable to our operations include, but are not limited to:

● the Anti-Kickback Statute, which will apply to our marketing

practices, educational programs, pricing policies and relationships with healthcare providers, by prohibiting, among other things, soliciting,

receiving, offering or providing remuneration intended to induce the purchase or recommendation of an item or service reimbursable under

a federal healthcare program, such as the Medicare or Medicaid programs.

A person or entity does not need to have actual knowledge of

this statute or specific intent to violate it to have committed a violation;

● federal civil and criminal false claims laws and civil monetary

penalty laws, including civil whistleblower or qui tam actions that prohibit, among other things, knowingly presenting, or causing to

be presented, claims for payment or approval to the federal government that are false or fraudulent, knowingly making a false statement

material to an obligation to pay or transmit money or property to the federal government or knowingly concealing or knowingly and improperly

avoiding or decreasing an obligation to pay or transmit money or property to the federal government.

The government may assert that a

claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for

purposes of the false claims statutes;

and its implementing regulations, which created federal criminal laws that prohibit, among

other things, executing a scheme to defraud any healthcare benefit program or making false

statements relating to healthcare matters.

A person or entity does not need to have actual

knowledge of these statutes or specific intent to violate them;

as amended by the Health Information Technology for Economic and Clinical Health Act of 2009,

and their implementing regulations, also imposes certain regulatory and contractual requirements

● HIPAA, and its implementing regulations, which created federal

criminal laws that prohibit, among other things, executing a scheme to defraud any healthcare benefit program or making false statements

relating to healthcare matters.

A person or entity does not need to have actual knowledge of these statutes or specific intent to violate

● HIPAA, as amended by the Health Information Technology for

Economic and Clinical Health Act of 2009, and their implementing regulations, also imposes certain regulatory and contractual requirements

regarding the privacy, security and transmission of individually identifiable health information;

“sunshine” requirements imposed by the ACA on device manufacturers regarding

any “transfer of value” made or distributed to physicians and teaching hospitals.

Failure to submit required information may result in civil monetary penalties of up to an

aggregate of $150,000 per year (or up to an aggregate of $1 million per year for “knowing

failures”), for all payments, transfers of value or ownership or investment interests

Medical Technologies Corporation

● federal “sunshine” requirements imposed by the

ACA on device manufacturers regarding any “transfer of value” made or distributed to physicians and teaching hospitals.

to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 per year (or up to an aggregate

of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests

that are not timely, accurately, and completely reported in an annual submission.

Manufacturers

must submit reports by the 90th day of each subsequent calendar year;

consumer protection and unfair competition laws, which broadly regulate marketplace activities

and activities that potentially harm consumers;

law equivalents of each of the above federal laws, such as anti-kickback and false claims

laws that may apply to items or services reimbursed by any third-party payor, including commercial

state laws that require device companies to comply with the industry’s voluntary

compliance guidelines and the relevant compliance guidance promulgated by the federal government

Manufacturers must submit reports by the 90th day of

each subsequent calendar year;

● federal consumer protection and unfair competition laws,

which broadly regulate marketplace activities and activities that potentially harm consumers;

● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that

may apply to items or services reimbursed by any third-party payor, including commercial insurers;

state laws that require device companies

to comply with the industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government

or otherwise restrict payments that may be made to healthcare providers;

state laws that

require device manufacturers to report information related to payments and other transfers

of value to physicians and other healthcare providers or marketing expenditures;

laws governing the privacy and security of certain health information, many of which differ

from each other in significant ways and often are not preempted by HIPAA;

risk of our being found in violation of these laws and regulations is increased by the fact that the scope and enforcement of these laws

is uncertain, many of them have not been fully interpreted by the regulatory authorities or the courts, their provisions are open to

a variety of interpretations, or they vary country by country.

We are unable to predict what additional federal, state or foreign legislation

or regulatory initiatives may be enacted in the future regarding our business or the healthcare industry in general, or what effect such

legislation or regulations may have on us.

Federal, state or foreign governments may (i) impose additional restrictions or adopt interpretations

of existing laws that could have a material adverse effect on us or (ii) challenge our current or future activities under these laws.

Any of these challenges could impact our reputation, business, financial condition and operating results.

our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us

now or in the future, we may be subject to penalties, including civil and criminal penalties, damages, fines, disgorgement of profits,

exclusion from governmental health care programs, and the curtailment or restructuring of our operations, any of which could adversely

affect our ability to operate our business and our financial results.

federal, state or foreign regulatory review to which we may become subject, regardless of the outcome, would be costly and time-consuming.

state laws that require device manufacturers to report information

related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures;

and state laws

governing the privacy and security of certain health information, many of which differ from each other in significant ways and often are

not preempted by HIPAA.

The risk of our being found in violation of these

laws and regulations is increased by the fact that the scope and enforcement of these laws is uncertain, many of them have not been fully

interpreted by the regulatory authorities or the courts, their provisions are open to a variety of interpretations, or they vary country

We are unable to predict what additional federal, state or foreign legislation or regulatory initiatives may be enacted in

the future regarding our business or the healthcare industry in general, or what effect such legislation or regulations may have on us.

Federal, state or foreign governments may (i) impose additional restrictions or adopt interpretations of existing laws that could have

a material adverse effect on us or (ii) challenge our current or future activities under these laws.

Any of these challenges could impact

our reputation, business, financial condition and operating results.

If our operations are found to be in violation

of any of the laws described above or any other governmental regulations that apply to us now or in the future, we may be subject to penalties,

including civil and criminal penalties, damages, fines, disgorgement of profits, exclusion from governmental health care programs, and

the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial

Any federal, state or foreign regulatory review to which we may become subject, regardless of the outcome, would be costly and

time-consuming.

For example, to enforce compliance with the federal

laws, the U.S.

Department of Justice, or DOJ, has recently increased its scrutiny of interactions between healthcare companies and healthcare

providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry.

with investigations can be time and resource consuming and can divert management’s attention from our core business.

Additionally,

if we settle an investigation with law enforcement or other regulatory agencies, we may be forced to agree to additional onerous compliance

and reporting requirements as part of a consent decree or corporate integrity agreement.

Any such investigation or settlement could increase

our costs or otherwise have an adverse effect on our business.

Medical Technologies Corporation

example, to enforce compliance with the federal laws, the U.S.

Department of Justice, or DOJ, has recently increased its scrutiny of

interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions

and settlements in the healthcare industry.

Dealing with investigations can be time and resource consuming and can divert management’s

attention from our core business.

Additionally, if we settle an investigation with law enforcement or other regulatory agencies, we may

be forced to agree to additional onerous compliance and reporting requirements as part of a consent decree or corporate integrity agreement.

Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.

may be liable if the FDA or another regulatory agency concludes that we have engaged in the off-label promotion of our products.

promotional materials and training methods must comply with FDA and other applicable laws and regulations, including the prohibition

of the promotion of the off-label use of our products.

Healthcare providers may use our products, if approved, off-label, as the FDA

does not restrict or regulate a physician’s choice of treatment within the practice of medicine.

However, if the FDA determines

that our promotional materials or training constitute promotion of an off-label use, it could request that we modify our training or

promotional materials or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter,

injunction, seizure, civil fine and criminal penalties.

It is also possible that other federal, state or foreign enforcement authorities

might take action if they consider our promotional or training materials to constitute promotion of an unapproved use, which could result

in significant fines or penalties.

Although we intend to train our marketing and direct sales force to not promote our products for uses

outside of their cleared uses and our policy will be to refrain from statements that could be considered off-label promotion of our products,

the FDA or another regulatory agency could disagree and conclude that we have engaged in off-label promotion.

In addition, the off-label

use of our products may increase the risk of product liability claims.

Product liability claims are expensive to defend and could result

in substantial damage awards against us and harm our reputation.

or regulatory healthcare reforms may have a material adverse effect on our business, financial condition, results or operations and cash

political, economic and regulatory influences are subjecting the healthcare industry to fundamental changes.

The sales of our products

depend in part on the availability of coverage and reimbursement from third-party payors such as government health administration authorities,

private health insurers, health maintenance organizations and other healthcare-related organizations.

Both the federal and state governments

in the United States continue to propose and pass new legislation and regulations designed to contain or reduce the cost of healthcare.

This legislation and regulation may result in decreased reimbursement for medical devices, which may further exacerbate industry-wide

pressure to reduce the prices charged for medical devices.

We may be liable if the FDA or another regulatory

agency concludes that we have engaged in the off-label promotion of our products.

Our promotional materials and training methods

must comply with FDA and other applicable laws and regulations, including the prohibition of the promotion of the off-label use of our

Healthcare providers may use our products, if approved, off-label, as the FDA does not restrict or regulate a physician’s

choice of treatment within the practice of medicine.

However, if the FDA determines that our promotional materials or training constitute

promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement

actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine and criminal penalties.

also possible that other federal, state or foreign enforcement authorities might take action if they consider our promotional or training

materials to constitute promotion of an unapproved use, which could result in significant fines or penalties.

Although we intend to train

our marketing and direct sales force to not promote our products for uses outside of their cleared uses and our policy will be to refrain

from statements that could be considered off-label promotion of our products, the FDA or another regulatory agency could disagree and

conclude that we have engaged in off-label promotion.

In addition, the off-label use of our products may increase the risk of product

liability claims.

Product liability claims are expensive to defend and could result in substantial damage awards against us and harm our

Legislative or regulatory healthcare reforms

may have a material adverse effect on our business, financial condition, results or operations and cash flows.

Recent political, economic and regulatory influences

are subjecting the healthcare industry to fundamental changes.

The sales of our products depend in part on the availability of coverage

and reimbursement from third-party payors such as government health administration authorities, private health insurers, health maintenance

organizations and other healthcare-related organizations.

Both the federal and state governments in the United States continue to propose

and pass new legislation and regulations designed to contain or reduce the cost of healthcare.

This legislation and regulation may result

in decreased reimbursement for medical devices, which may further exacerbate industry-wide pressure to reduce the prices charged for medical

This could harm our ability to market our products and generate sales.

addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business

and our products.

Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen

review times of our products.

Delays in receipt of or failure to receive regulatory clearances or approvals for our products would harm

our business, financial condition and operating results.

one often stated goal of healthcare reform is to expand coverage to more individuals, it also involves increased government price controls,

additional regulatory mandates and other measures designed to constrain medical costs.

For example, the ACA and Health Care and Education

Affordability Reconciliation Act of 2010 were enacted into law in the U.S.

In addition, FDA regulations and guidance are

often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products.

Any new regulations or

revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of our products.

receipt of or failure to receive regulatory clearances or approvals for our products would harm our business, financial condition and

operating results.

While one often stated goal of healthcare reform

is to expand coverage to more individuals, it also involves increased government price controls, additional regulatory mandates and other

measures designed to constrain medical costs.

For example, the ACA and Health Care and Education Affordability Reconciliation Act of 2010

were enacted into law in the U.S.

in March 2010.

Certain provisions of this law, including comparative

effectiveness research, pilot programs to evaluate alternative payment methodologies and other changes to the payment systems, have started

changing the way healthcare is delivered, reimbursed and funded.

While the extent to which it has affected our business is not clear,

these changes, over the long-term, may adversely affect our business and results of operations.

Certain provisions of this law, including comparative effectiveness research, pilot programs

to evaluate alternative payment methodologies and other changes to the payment systems, have started changing the way healthcare is delivered,

reimbursed and funded.

While the extent to which it has affected our business is not clear, these changes, over the long-term, may adversely

affect our business and results of operations.

The current U.S.

administration may attempt

to reverse some of the previous administration’s changes to the ACA, particularly related to healthcare coverage for the uninsured,

and is further expected to introduce more ambitious healthcare legislation, which could include what is commonly referred to as a “public

option” or changes to Medicare age requirements.

If passed, this legislation would lead to increased coverage levels and utilization

however, at this point, the impact of any such changes is unclear because specific changes have not been enacted or implemented.

administration may attempt to reverse some of the previous administration’s

changes to the ACA, particularly related to healthcare coverage for the uninsured, and is further expected to introduce more ambitious

healthcare legislation, which could include what is commonly referred to as a “public option” or changes to Medicare age requirements.

If passed, this legislation would lead to increased coverage levels and utilization of services;

however, at this point, the impact of

any such changes is unclear because specific changes have not been enacted or implemented.

We cannot predict whether any additional healthcare

reform proposals will be adopted or how such proposals may impact our business and operations.

However, any changes that lower reimbursements

for either our products or procedures using our products, reduce medical procedure volumes, increase cost containment pressures on us

or others in the healthcare sector, or impose additional or heightened regulatory requirements could adversely affect our business and

results of operations.

Medical Technologies Corporation

cannot predict whether any additional healthcare reform proposals will be adopted or how such proposals may impact our business and operations.

However, any changes that lower reimbursements for either our products or procedures using our products, reduce medical procedure volumes,

increase cost containment pressures on us or others in the healthcare sector, or impose additional or heightened regulatory requirements

could adversely affect our business and results of operations.

Related to our Common Stock

price of our Common Stock might fluctuate significantly, and you could lose all or part of your investment.

in the market price of our Common Stock may prevent you from being able to sell your shares of our Common Stock at or above the price

you paid for your shares.

The trading price of our Common Stock may be volatile and subject to wide price fluctuations in response to

various factors, including:

or anticipated fluctuations in our quarterly financial and operating results;

progress toward developing our cortical strip and sheet electrode technology;

commencement, enrollment and results of our future clinical trials;

results from, delays in or termination of our clinical trials;

regulatory decisions, including failure to receive regulatory approval;

● publication

of research reports about us or our industry or positive or negative recommendations or withdrawal

of research coverage by securities analysts, if any;

● perceptions

about the market acceptance of our products and the recognition of our brand;

publicity about our products or industry in general;

performance of the equity markets;

● introduction

of products, or announcements of significant contracts, licenses or acquisitions, by us or

our competitors;

● legislative,

political or regulatory developments;

or departures of key personnel;

or actual litigation and government investigations;

● third-party

promotional activities, which are subject to ongoing regulatory obligations;

of shares of our Common Stock by us or members of our management;

economic conditions.

Risks Related to our Common Stock

The price of our Common Stock might fluctuate

significantly, and you could lose all or part of your investment.

Volatility in the market price of our Common Stock

may prevent you from being able to sell your shares of our Common Stock at or above the price you paid for your shares.

The trading price

of our Common Stock may be volatile and subject to wide price fluctuations in response to various factors, including:

● actual or anticipated fluctuations in our quarterly financial

and operating results;

● our progress toward developing our cortical strip and sheet

electrode technology;

● the commencement, enrollment and results of our future clinical

● adverse results from, delays in or termination of our clinical

● adverse regulatory decisions, including failure to receive

regulatory approval;

● publication of research reports about us or our industry

or positive or negative recommendations or withdrawal of research coverage by securities analysts, if any;

● perceptions about the market acceptance of our products and

the recognition of our brand;

● adverse publicity about our products or industry in general;

● overall performance of the equity markets;

● introduction of products, or announcements of significant

contracts, licenses or acquisitions, by us or our competitors;

● legislative, political or regulatory developments;

● additions or departures of key personnel;

● threatened or actual litigation and government investigations;

● third-party promotional activities, which are subject to

ongoing regulatory obligations;

● sale of shares of our Common Stock by us or members of our

● general economic conditions.

These and other factors might cause the market

price of our Common Stock to fluctuate substantially, which may negatively affect the liquidity of our Common Stock.

In addition, in recent

years, the stock market has experienced significant price and volume fluctuations.

This volatility has had a significant impact on the

market price of securities issued by many companies across many industries.

The changes frequently appear to occur without regard to the

operating performance of the affected companies.

Accordingly, the price of our Common Stock could fluctuate based upon factors that have

little or nothing to do with our Company, and these fluctuations could materially reduce our share price.

Securities class action litigation has often been

instituted against companies following periods of volatility in the overall market and in the market price of a company’s securities.

This litigation, if instituted against us, could result in substantial costs, divert our management’s attention and resources, and

harm our business, operating results and financial condition.

Medical Technologies Corporation

and other factors might cause the market price of our Common Stock to fluctuate substantially, which may negatively affect the liquidity

of our Common Stock.

In addition, in recent years, the stock market has experienced significant price and volume fluctuations.

This volatility

has had a significant impact on the market price of securities issued by many companies across many industries.

The changes frequently

appear to occur without regard to the operating performance of the affected companies.

Accordingly, the price of our Common Stock could

fluctuate based upon factors that have little or nothing to do with our Company, and these fluctuations could materially reduce our share

class action litigation has often been instituted against companies following periods of volatility in the overall market and in the

market price of a company’s securities.

This litigation, if instituted against us, could result in substantial costs, divert our

management’s attention and resources, and harm our business, operating results and financial condition.

failure to maintain an effective system of internal controls could result in material misstatements of our financial statements or cause

us to fail to meet our reporting obligations or fail to prevent fraud in which case, our stockholders could lose confidence in our financial

reporting, which would harm our business and could negatively impact the price of our stock.

are required to comply with the internal control evaluation and certification requirements of Section 404 of the Sarbanes-Oxley Act of

2002 (“SOX”) and management is required to report annually on our internal control over financial reporting.

Our independent

registered public accounting firm will not be required to formally attest to the effectiveness of our internal control over financial

reporting pursuant to Section 404(b) of SOX until the date we have a public float of $75 million or greater.

we fail to maintain effective internal controls and procedures for financial reporting, it could result in material misstatements in

the annual or interim financial statements that would not be prevented or detected in a timely manner.

We identified material weaknesses

in our internal control over financial reporting in 2018, and we cannot assure you that material weaknesses or significant deficiencies

will not occur in the future and that we will be able to remediate such weaknesses or deficiencies in a timely manner, which could impair

our ability to accurately and timely report our financial position, results of operations or cash flows.

intend to issue more shares to raise capital, which will result in substantial dilution.

certificate of incorporation authorizes the issuance of a maximum of 100,000,000 shares of Common Stock and 10,000,000 shares of preferred

Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of

equity, debt financings, or other capital sources.

Any additional financings effected by us may result in the issuance of additional

securities without stockholder approval and the substantial dilution in the percentage of Common Stock held by our then existing stockholders.

Moreover, the Common Stock issued in any such transaction may be valued on an arbitrary or non-arm’s-length basis by our management,

resulting in an additional reduction in the percentage of Common Stock held by our current stockholders.

Our Board has the power to issue

any or all of such authorized but unissued shares without stockholder approval.

To the extent that additional shares of Common Stock

are issued, dilution to the interests of our stockholders will occur and the rights of the holder of Common Stock might be materially

and adversely affected.

of September 30, 2022, we had outstanding warrants to purchase an aggregate of 7,103,344 shares of Common Stock at a weighted average

exercise price of $5.98 per share, and options to purchase an aggregate of 1,239,915 shares of Common Stock at a weighted average exercise

price of $5.40 per share.

For a description of our outstanding warrants and information about the number of shares of Common Stock for

which they are exercisable, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations-Liquidity

and Capital Resources-Historical Capital Resources.” To the extent these outstanding options or warrants are exercised, there will

be further dilution to holders of our Common Stock.

Any failure to maintain an effective system

of internal controls over our financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could result in material

misstatements of our financial statements or cause us to fail to meet our reporting obligations or fail to prevent fraud in which case,

our stockholders could lose confidence in our financial reporting, which would harm our business and could negatively impact the price

of our stock.

We are required to comply with the internal control

evaluation and certification requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (“SOX”) and management is required

to report annually on our internal control over financial reporting.

This assessment includes disclosure of any material weaknesses identified

by our management in our internal control over financial reporting.

Although we prepare our financial statements in accordance with accounting

principles generally accepted in the United States, our internal accounting controls may not meet all standards applicable to companies

with publicly traded securities.

Our independent registered public accounting firm will not be required to formally attest to the effectiveness

of our internal control over financial reporting pursuant to Section 404(b) of SOX until the date we have a public float of $75 million

If we fail to maintain effective internal controls

and procedures for financial reporting, it could result in material misstatements in the annual or interim financial statements that would

not be prevented or detected in a timely manner.

In that case, we could become subject to regulatory sanction or investigation.

these outcomes could damage investor confidence in the accuracy and reliability of our financial statements.

Our management has concluded

that our internal controls over financial reporting were, and continue to be, effective as of September 30, 2023.

However, we identified

material weaknesses in our internal control over financial reporting in 2018, and we cannot assure you that material weaknesses or significant

deficiencies will not occur in the future and that we will be able to remediate such weaknesses or deficiencies in a timely manner, which

could impair our ability to accurately and timely report our financial position, results of operations or cash flows.

If we are not able

to maintain effective internal control over financial reporting, our financial statements, including related disclosures, may be inaccurate,

which could have a material adverse effect on our business.

We intend to issue more shares to raise

capital, which will result in substantial dilution.

Our certificate of incorporation authorizes the

issuance of a maximum of 100,000,000 shares of Common Stock and 10,000,000 shares of preferred stock.

Until we can generate significant

revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital

Any additional financings effected by us may result in the issuance of additional securities without stockholder approval and

the substantial dilution in the percentage of Common Stock held by our then existing stockholders.

Moreover, the Common Stock issued in

any such transaction may be valued on an arbitrary or non-arm’s-length basis by our management, resulting in an additional reduction

in the percentage of Common Stock held by our current stockholders.

Our Board has the power to issue any or all of such authorized but

unissued shares without stockholder approval.

To the extent that additional shares of Common Stock are issued, dilution to the interests

of our stockholders will occur and the rights of the holder of Common Stock might be materially and adversely affected.

As of September 30, 2023, we had outstanding warrants

to purchase an aggregate of 6,202,426 shares of Common Stock at a weighted average exercise price of $5.92 per share, and options to purchase

an aggregate of 1,708,427 shares of Common Stock at a weighted average exercise price of $4.34 per share.

For a description of our outstanding

warrants and information about the number of shares of Common Stock for which they are exercisable, see “Management’s Discussion

and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Capital Resources.” To

the extent these outstanding options or warrants are exercised, there will be further dilution to holders of our Common Stock.

Anti-takeover provisions in the Company’s

certificate of incorporation and bylaws may prevent or frustrate attempts by stockholders to change the Board or current management and

could make a third-party acquisition of the Company difficult.

The Company’s certificate of incorporation

and bylaws contain provisions that may discourage, delay or prevent a merger, acquisition or other change in control that stockholders

may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares.

our certificate of incorporation permits the Board without stockholder approval to issue up to 10,000,000 shares of preferred stock and

to fix the designation, power, preferences, and rights of those shares.

Furthermore, our Board has the ability to increase the size of

the Board and fill the newly created vacancies without stockholder approval.

These provisions could limit the price that investors might

be willing to pay in the future for shares of the Common Stock.

Medical Technologies Corporation

Anti-takeover

provisions in the Company’s certificate of incorporation and bylaws may prevent or frustrate attempts by stockholders to change

the Board or current management and could make a third-party acquisition of the Company difficult.

Company’s certificate of incorporation and bylaws contain provisions that may discourage, delay or prevent a merger, acquisition

or other change in control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive

a premium for their shares.

For example, our certificate of incorporation permits the Board without stockholder approval to issue up

to 10,000,000 shares of preferred stock and to fix the designation, power, preferences, and rights of those shares.

Furthermore, our

Board has the ability to increase the size of the Board and fill the newly created vacancies without stockholder approval.

These provisions

could limit the price that investors might be willing to pay in the future for shares of the Common Stock.

are a smaller reporting company, and the reduced reporting requirements applicable to smaller reporting companies may make our Common

Stock less attractive to investors.

are a “smaller reporting company” as defined in Section 12 of the Exchange Act.

For as long as we continue to be a smaller

reporting company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies

that are not smaller reporting companies such as, reduced disclosure obligations regarding executive compensation in our annual and periodic

reports and proxy statements and stockholder approval of any golden parachute payments not previously approved.

We will remain a “smaller

reporting company” as long as (i) our public float remains less than $250 million or (ii) our annual revenues are less than $100

million and we either have no public float, or our public float is less than $700 million.

Public float is measured as of the last business

day of our most recently-completed second fiscal quarter, and annual revenues are as of the most recently completed fiscal year for which

audited financial statements are available.

We cannot predict if investors will find our Common Stock less attractive because we may

rely on these exemptions.

If some investors find our Common Stock less attractive as a result, there may be a less active trading market

for our Common Stock and our stock price may be more volatile.

have not paid dividends in the past and do not expect to pay dividends in the future, and any return on investment may be limited to

the value of our stock.

have never declared or paid cash dividends on our capital stock.

We currently intend to retain all available funds and any future earnings

for use in the operation and expansion of our business and do not anticipate paying any cash dividends in the foreseeable future.

you may have to sell some or all of your shares of our Common Stock in order to generate cash flow from your investment.

receive a gain on your investment when you sell shares and you may lose the entire amount of the investment.

securities or industry analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business

or our market, our stock price and trading volume could decline.

trading market for our Common Stock will be influenced by the research and reports that securities or industry analysts publish about

us and our business.

Securities or industry analysts may elect not to provide coverage of our Common Stock, and such lack of coverage

may adversely affect the market price of our Common Stock.

In the event we do not secure additional securities or industry analyst coverage,

we will not have any control over the analysts or the content and opinions included in their reports.

The price of our stock could decline

if one or more securities or industry analysts downgrade our stock or issue other unfavorable commentary or research.

If one or more

securities or industry analysts ceases coverage of our Company or fails to publish reports on us regularly, demand for our stock could

decrease, which in turn could cause our stock price or trading volume to decline.

we fail to comply with the continued listing standards of the Nasdaq Capital Market, our Common Stock could be delisted.

If it is delisted,

our Common Stock and the liquidity of our Common Stock would be impacted.

continued listing of our Common Stock on Nasdaq is contingent on NeuroOne’s continued compliance with a number of listing standards.

There is no assurance that NeuroOne will remain in compliance with these standards.

Delisting from Nasdaq would adversely affect our

ability to raise additional financing through the public or private sale of equity securities, significantly affect the ability of investors

to trade our securities and negatively affect the value and liquidity of our Common Stock.

Delisting also could limit our strategic alternatives

and attractiveness to potential counterparties and have other negative results, including the potential loss of employee confidence,

the loss of institutional investors or interest in business development opportunities.

Moreover, NeuroOne committed in connection with

the sale of securities to use commercially reasonable efforts to maintain the listing of its Common Stock during such time that certain

warrants are outstanding.

We are a smaller reporting company, and

the reduced reporting requirements applicable to smaller reporting companies may make our Common Stock less attractive to investors.

We are a “smaller reporting company”

as defined in Section 12 of the Exchange Act.

For as long as we continue to be a smaller reporting company, we may take advantage of exemptions

from various reporting requirements that are applicable to other public companies that are not smaller reporting companies such as, reduced

disclosure obligations regarding executive compensation in our annual and periodic reports and proxy statements and stockholder approval

of any golden parachute payments not previously approved.

We will remain a “smaller reporting company” as long as (i) our

public float remains less than $250 million or (ii) our annual revenues are less than $100 million and we either have no public float,

or our public float is less than $700 million.

Public float is measured as of the last business day of our most recently-completed second

fiscal quarter, and annual revenues are as of the most recently completed fiscal year for which audited financial statements are available.

We cannot predict if investors will find our Common Stock less attractive because we may rely on these exemptions.

If some investors find

our Common Stock less attractive as a result, there may be a less active trading market for our Common Stock and our stock price may be

more volatile.

We have not paid dividends in the past and

do not expect to pay dividends in the future, and any return on investment may be limited to the value of our stock.

We have never declared or paid cash dividends

on our capital stock.

We currently intend to retain all available funds and any future earnings for use in the operation and expansion

of our business and do not anticipate paying any cash dividends in the foreseeable future.

Accordingly, you may have to sell some or all

of your shares of our Common Stock in order to generate cash flow from your investment.

You may not receive a gain on your investment

when you sell shares and you may lose the entire amount of the investment.

If securities or industry analysts do not

publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading

volume could decline.

The trading market for our Common Stock will be

influenced by the research and reports that securities or industry analysts publish about us and our business.

Securities or industry

analysts may elect not to provide coverage of our Common Stock, and such lack of coverage may adversely affect the market price of our

Common Stock.

In the event we do not secure additional securities or industry analyst coverage, we will not have any control over the

analysts or the content and opinions included in their reports.

The price of our stock could decline if one or more securities or industry

analysts downgrade our stock or issue other unfavorable commentary or research.

If one or more securities or industry analysts ceases

coverage of our Company or fails to publish reports on us regularly, demand for our stock could decrease, which in turn could cause our

stock price or trading volume to decline.

If we fail to comply with the continued

listing standards of the Nasdaq Capital Market, our Common Stock could be delisted.

If it is delisted, our Common Stock and the liquidity

of our Common Stock would be impacted.

The continued listing of our Common Stock on Nasdaq

is contingent on NeuroOne’s continued compliance with a number of listing standards.

There is no assurance that NeuroOne will remain

in compliance with these standards.

Delisting from Nasdaq would adversely affect our ability to raise additional financing through the

public or private sale of equity securities, significantly affect the ability of investors to trade our securities and negatively affect

the value and liquidity of our Common Stock.

Delisting also could limit our strategic alternatives and attractiveness to potential counterparties

and have other negative results, including the potential loss of employee confidence, the loss of institutional investors or interest

in business development opportunities.

Moreover, NeuroOne committed in connection with the sale of securities to use commercially reasonable

efforts to maintain the listing of its Common Stock during such time that certain warrants are outstanding.

Medical Technologies Corporation

Related to the Acquisition

may be subject to unknown risks as a result of our completed Acquisition by Original Source Entertainment, Inc.

Source Entertainment, Inc., which was renamed NeuroOne Medical Technologies Corporation in connection with the Acquisition, was formed

to license songs to the television and movie industry and has generated very little revenues.

Prior to the Acquisition, its operations

have been primarily limited to organizational, start-up, and capital formation activities, with no employees other than the former officers.

In connection with the Acquisition, the liabilities existing in Original Source Entertainment, Inc.

at the time of the Acquisition were

cancelled or paid by a related party, as required by the Merger Agreement with NeuroOne, Inc.

and OSOK Acquisition Company (the “Merger

Despite this requirement and the representations and warranties of Original Source Entertainment, Inc.

in the Merger

Agreement, there may be unknown liabilities, or liabilities that were known but believed to be immaterial, related to the business of

Original Source Entertainment, Inc.

Our Common Stock has been, and may in the

future be subject to the “penny stock” rules of the SEC, which makes transactions in our stock cumbersome and may reduce the

value of an investment in our stock.

The SEC has adopted regulations which generally

define a “penny stock” as an equity security that has a market price of less than $5.00 per share, subject to specific exemptions.

The SEC’s penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from the rules,

to deliver a standardized risk disclosure document that provides information about penny stocks and the risks in the penny stock market.

The broker-dealer must also provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer

and the salesperson in the transaction, and monthly account statements showing the market value of each penny stock held in the customer’s

In addition, the penny stock rules generally require that before a transaction in a penny stock occurs, the broker-dealer must

make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s

agreement to the transaction.

If our Common Stock is subject to the “penny stock” rules, these rules may restrict the ability

of brokers-dealers to sell our Common Stock and may affect the ability of investors to sell their shares, until our Common Stock no longer

is considered a penny stock.

There can be no assurance that we will be

able to comply with Nasdaq’s continued listing standards, a failure of which could result in a de-listing of our common stock.

There is no assurance that we will continue to

comply with the applicable Nasdaq listing standards.

In order to maintain the listing of our common stock on Nasdaq, Nasdaq requires that

the trading price of a company’s listed stock on Nasdaq remain above one dollar in order for such stock to remain listed.

stock trades below one dollar for more than 30 consecutive trading days, then it is subject to delisting from Nasdaq.

In addition, to

maintain a listing on Nasdaq, we must satisfy minimum financial and other continued listing requirements and standards, including those

regarding director independence and independent committee requirements, minimum stockholders’ equity, and certain corporate governance

requirements.

If we are unable to satisfy these requirements or standards, we could be subject to delisting, which would have a negative

effect on the price of our common stock and warrants and would impair your ability to sell or purchase our common stock and warrants when

you wish to do so.

In the event of a delisting, we would expect to take actions to restore our compliance with the listing requirements,

but we can provide no assurance that any such action taken by us would allow our common stock and/or warrants to become listed again,

stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the minimum bid

price requirement, or prevent future non-compliance with the listing requirements.

Risks Related to the Acquisition

We may be subject to unknown risks as a

result of our completed Acquisition by Original Source Entertainment, Inc.

Original Source Entertainment, Inc., which was

renamed NeuroOne Medical Technologies Corporation in connection with the Acquisition, was formed to license songs to the television and

movie industry and has generated very little revenues.

Prior to the Acquisition, its operations have been primarily limited to organizational,

start-up, and capital formation activities, with no employees other than the former officers.

In connection with the Acquisition, the

liabilities existing in Original Source Entertainment, Inc.

at the time of the Acquisition were cancelled or paid by a related party,

as required by the Merger Agreement with NeuroOne, Inc.

and OSOK Acquisition Company (the “Merger Agreement”).

requirement and the representations and warranties of Original Source Entertainment, Inc.

in the Merger Agreement, there may be unknown

liabilities, or liabilities that were known but believed to be immaterial, related to the business of Original Source Entertainment, Inc.

that may become material liabilities we are subject to in the future.

If we are subject to material

liabilities as a result of the conduct of Original Source Entertainment, Inc., we may have limited recourse for such liabilities, which

could have a material impact on our business and stock price.

risks may exist since we were engaged in a transaction that can be generally characterized as a “reverse merger” with a shell

Securities analysts of major brokerage firms may not provide coverage of the Company since there is little incentive to brokerage

firms to recommend the purchase of the Common Stock.

No assurance can be given that brokerage firms will want to conduct any secondary

in tax laws or exposure to additional income tax liabilities could have a material impact on our business, results of operations, financial

condition and cash flows.

are subject to income and other non-income-based taxes and tariffs in the U.S., and our operations, plans and results are affected by

tax and other initiatives.

The rules dealing with U.S.

federal, state and local income taxation are constantly under review by persons

involved in the legislative process and by the Internal Revenue Service, the U.S.

If we are subject to material liabilities as a result of the conduct

of Original Source Entertainment, Inc., we may have limited recourse for such liabilities, which could have a material impact on our business

and stock price.

Additional risks may exist since we were engaged

in a transaction that can be generally characterized as a “reverse merger” with a shell company.

Securities analysts of major

brokerage firms may not provide coverage of the Company since there is little incentive to brokerage firms to recommend the purchase of

the Common Stock.

No assurance can be given that brokerage firms will want to conduct any secondary offerings.

General Risk Factors

Changes in tax laws or exposure to additional

income tax liabilities could have a material impact on our business, results of operations, financial condition and cash flows.

We are subject to income and other non-income-based

taxes and tariffs in the U.S., and our operations, plans and results are affected by tax and other initiatives.

The rules dealing with

federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal

Revenue Service, the U.S.

Treasury Department, and state/local taxing authorities.

The tax laws in the U.S.

could change on a prospective or retroactive basis, and any such changes could materially adversely affect our

business, our results of operations, our effective tax rate, and holders of our common stock.

We cannot predict whether, when, in what

form, or with what effective dates, tax laws, regulations and rulings may be enacted, promulgated or decided, which could result in an

increase in our, or our stockholders’, tax liability or require changes in the manner in which we operate in order to minimize

increases in our tax liability.

In recent years, many such changes have been made and changes are likely to continue to occur in the

Future changes in tax laws could have a material adverse effect on our business, cash flow, financial condition, results of operations,

tax provision, cash tax liability, and effective tax rate.

For example, in August 2022, the Inflation Reduction Act of 2022 (“IRA”)

was enacted into law.

The IRA includes a 15% corporate alternative minimum tax and a 1% excise tax on share repurchases.

urge investors to consult with their legal and tax advisers regarding the implications of potential changes in tax laws on an investment

in our common stock.

are also subject to regular reviews, examinations, and audits by the Internal Revenue Service and other taxing authorities with respect

to our taxes.

Although we believe our tax estimates are reasonable, if a taxing authority disagrees with the positions we have taken,

we could face additional tax liability, including interest and penalties.

can be no assurance that payment of such additional amounts upon final adjudication of any disputes will not have a material impact on

our results of operations and financial position.

Medical Technologies Corporation

may seek to grow our business through acquisitions of complementary products or technologies, and the failure to complete acquisitions,

or the failure to integrate them with our existing business, could harm our business, financial condition and operating results.

time to time, we may consider opportunities to acquire other companies, products or technologies that may enhance our product platform

or technology, expand the breadth of our markets or customer base, or advance our business strategies.

The success of our strategy relating

to future acquisitions, investments or alliances will depend on a number of factors, including our ability to:

suitable opportunities for acquisition, investment or alliance, if at all;

acquisition, investment or alliance opportunities within our capital capacity and prioritize

those investments to execute on our strategy;

our due diligence process to uncover potential issues and liabilities with targets;

any future acquisition, investment or alliance on terms acceptable to us, if at all;

acquisitions, investments or alliances in a timely manner on terms that are satisfactory

to us, if at all;

● successfully

integrate and operate acquired businesses;

● successfully

identify and retain key target employees;

with applicable laws and regulations;

intellectual property and to prevail in litigation related to newly acquired technologies;

the acquired products or technologies;

uniform standards, procedures, controls and policies;

costs associated with acquisitions;

the diversion of management’s attention from our existing business;

risks associated with entering new markets in which we have limited or no experience;

legal and accounting costs relating to the acquisitions or compliance with regulatory matters.

have no current commitments with respect to any acquisition.

We do not know if we will be able to identify acquisitions we deem suitable,

whether we will be able to successfully complete any such acquisitions on favorable terms or at all, or whether we will be able to successfully

integrate any acquired products or technologies.

Our potential inability to integrate any acquired products or technologies effectively

may adversely affect our business, operating results and financial condition.

Medical Technologies Corporation

future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

are highly dependent on the management, research and development, clinical, financial and business development expertise of our officers

and advisory board members.

Although we have an employment agreement with David Rosa, he (and each of our other key employees) may terminate

his employment with us at any time and will continue to be able to do so.

We do not maintain “key person” insurance for any

of our executives or employees.

and retaining qualified scientific and clinical personnel will also be critical to our success.

The loss of the services of our executive

officers or other key employees could impede the achievement of our research, development and commercialization objectives and seriously

harm our ability to successfully implement our business strategy.

Furthermore, replacing executive officers and key employees may be

difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills

and experience required to successfully develop, gain regulatory approval of and commercialize our products.

Competition to hire from

this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the

competition among numerous medical device companies for similar personnel, many of which have greater financial and other resources dedicated

to attracting and retaining personnel.

We also experience competition for the hiring of scientific and clinical personnel from universities

and research institutions.

In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us

in formulating our research and development and commercialization strategy.

Our consultants and advisors may be employed by employers

other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to

If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited.

negative economic conditions could adversely affect us, our customers and third-party partners, manufactures or suppliers, if any, which

could harm our financial condition.

are subject to the risks arising from adverse changes in general economic and market conditions, including, but not limited to, changes

related to the COVID-19 pandemic.

Uncertainty about future economic conditions could negatively impact our existing and potential customers,

adversely affect the financial ability of health insurers to pay claims, adversely impact our expenses and ability to obtain financing

of our operations, and cause delays or other problems with key suppliers.

spending in the United States has been, and is expected to continue to be, under significant pressure and there are many initiatives

to reduce healthcare costs.

As a result, we believe that some insurers are scrutinizing insurance claims more rigorously and delaying

or denying coverage and reimbursement more often.

Because the sale, if approved, of our cortical strip, grid electrode and depth electrode

technology under development will generally depend on the availability of third-party coverage and reimbursement, any delay or decline

in coverage and reimbursement will adversely affect our sales.

have incurred, and may continue to incur increased costs and demands upon management as a result of being a public company.

a public company in the United States, we incur significant legal, accounting and other costs.

These additional costs could negatively

affect our financial results.

In addition, changing laws, regulations and standards relating to corporate governance and public disclosure,

including regulations implemented by the SEC and the stock exchange on which we may list our Common Stock, may increase legal and financial

compliance costs and make some activities more time-consuming.

These laws, regulations and standards are subject to varying interpretations

and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.

We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general

and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance

If, notwithstanding our efforts to comply with new laws, regulations and standards, we fail to comply, regulatory authorities

may initiate legal proceedings against us and our business may be harmed.

Medical Technologies Corporation

to comply with these rules might also make it more difficult for us to obtain some types of insurance, including director and officer

liability insurance, and we might be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain

the same or similar coverage.

The impact of these events could also make it more difficult for us to attract and retain qualified persons

to serve on our Board, on committees of our Board or as members of senior management.

could change on a prospective

or retroactive basis, and any such changes could materially adversely affect our business, our results of operations, our effective tax

rate, and holders of our common stock.

We cannot predict whether, when, in what form, or with what effective dates, tax laws, regulations

and rulings may be enacted, promulgated or decided, which could result in an increase in our, or our stockholders’, tax liability

or require changes in the manner in which we operate in order to minimize increases in our tax liability.

In recent years, many such changes

have been made and changes are likely to continue to occur in the future.

Future changes in tax laws could have a material adverse effect

on our business, cash flow, financial condition, results of operations, tax provision, cash tax liability, and effective tax rate.

example, in August 2022, the Inflation Reduction Act of 2022 (“IRA”) was enacted into law.

The IRA includes a 15% corporate

alternative minimum tax and a 1% excise tax on share repurchases.

NeuroOne Medical Technologies

We urge investors to consult with their legal

and tax advisers regarding the implications of potential changes in tax laws on an investment in our common stock.

We are also subject to regular reviews, examinations,

and audits by the Internal Revenue Service and other taxing authorities with respect to our taxes.

Although we believe our tax estimates

are reasonable, if a taxing authority disagrees with the positions we have taken, we could face additional tax liability, including interest

and penalties.

There can be no assurance that payment of such additional amounts upon final adjudication of any disputes will not have

a material impact on our results of operations and financial position.

We may seek to grow our business through

acquisitions of complementary products or technologies, and the failure to complete acquisitions, or the failure to integrate them with

our existing business, could harm our business, financial condition and operating results.

From time to time, we may consider opportunities

to acquire other companies, products or technologies that may enhance our product platform or technology, expand the breadth of our markets

or customer base, or advance our business strategies.

The success of our strategy relating to future acquisitions, investments or alliances

will depend on a number of factors, including our ability to:

● identify suitable opportunities for acquisition, investment or alliance, if at all;

● manage acquisition, investment or alliance opportunities within our capital capacity and prioritize those

investments to execute on our strategy;

● manage our due diligence process to uncover potential issues and liabilities with targets;

● finance any future acquisition, investment or alliance on terms acceptable to us, if at all;

● complete acquisitions, investments or alliances in a timely manner on terms that are satisfactory to us,

● successfully integrate and operate acquired businesses;

● successfully identify and retain key target employees;

● comply with applicable laws and regulations;

● protect intellectual property and to prevail in litigation related to newly acquired technologies;

● assimilate the acquired products or technologies;

● maintain uniform standards, procedures, controls and policies;

● anticipate costs associated with acquisitions;

● avoid the diversion of management’s attention from our existing business;

● manage risks associated with entering new markets in which we have limited or no experience;

● manage legal and accounting costs relating to the acquisitions or compliance with regulatory matters.

NeuroOne Medical Technologies

We have no current commitments with respect to

any acquisition.

We do not know if we will be able to identify acquisitions we deem suitable, whether we will be able to successfully

complete any such acquisitions on favorable terms or at all, or whether we will be able to successfully integrate any acquired products

or technologies.

Our potential inability to integrate any acquired products or technologies effectively may adversely affect our business,

operating results and financial condition.

Our future success depends on our ability

to retain key executives and to attract, retain and motivate qualified personnel.

We are highly dependent on the management, research

and development, clinical, financial and business development expertise of our officers and advisory board members.

Although we have an

employment agreement with our Chief Executive Officer, David Rosa, he (and each of our other key employees) may terminate his employment

with us at any time and will continue to be able to do so.

We do not maintain “key person” insurance for any of our executives

or employees.

Recruiting and retaining qualified scientific

and clinical personnel will also be critical to our success.

The loss of the services of our executive officers or other key employees

could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully

implement our business strategy.

Furthermore, replacing executive officers and key employees may be difficult and may take an extended

period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully

develop, gain regulatory approval of and commercialize our products.

Competition to hire from this limited pool is intense, and we may

be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous medical device

companies for similar personnel, many of which have greater financial and other resources dedicated to attracting and retaining personnel.

We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.

we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development

and commercialization strategy.

Our consultants and advisors may be employed by employers other than us and may have commitments under

consulting or advisory contracts with other entities that may limit their availability to us.

If we are unable to continue to attract

and retain high quality personnel, our ability to pursue our growth strategy will be limited.

Prolonged negative economic conditions could

adversely affect us, our customers and third-party partners, manufactures or suppliers, if any, which could harm our financial condition.

We are subject to the risks arising from adverse

changes in general economic and market conditions.

Uncertainty about future economic conditions could negatively impact our existing and

potential customers, adversely affect the financial ability of health insurers to pay claims, adversely impact our expenses and ability

to obtain financing of our operations, and cause delays or other problems with key suppliers.

Healthcare spending in the United States has been,

and is expected to continue to be, under significant pressure and there are many initiatives to reduce healthcare costs.

we believe that some insurers are scrutinizing insurance claims more rigorously and delaying or denying coverage and reimbursement more

Because the sale, if approved, of our cortical strip, grid electrode and depth electrode technology under development will generally

depend on the availability of third-party coverage and reimbursement, any delay or decline in coverage and reimbursement will adversely

affect our sales.

We have incurred, and may continue to incur

increased costs and demands upon management as a result of being a public company.

As a public company in the United States, we incur

significant legal, accounting and other costs.

These additional costs could negatively affect our financial results.

In addition, changing

laws, regulations and standards relating to corporate governance and public disclosure, including regulations implemented by the SEC and

the stock exchange on which we may list our Common Stock, may increase legal and financial compliance costs and make some activities more

time-consuming.

These laws, regulations and standards are subject to varying interpretations and, as a result, their application in practice

may evolve over time as new guidance is provided by regulatory and governing bodies.

We intend to invest resources to comply with evolving

laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s

time and attention from revenue-generating activities to compliance activities.

If, notwithstanding our efforts to comply with new laws,

regulations and standards, we fail to comply, regulatory authorities may initiate legal proceedings against us and our business may be

Failure to comply with these rules might also make it more difficult for us to obtain some types of insurance, including director

and officer liability insurance, and we might be forced to accept reduced policy limits and coverage or incur substantially higher costs

to obtain the same or similar coverage.

The impact of these events could also make it more difficult for us to attract and retain qualified

persons to serve on our Board, on committees of our Board or as members of senior management.

NeuroOne Medical Technologies

UNRESOLVED STAFF COMMENTS

Not applicable.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors